Surgical Staplers & Staples
FDA to Reclassify Surgical Staplers and Staples
FDA Recommends the Reclassification of Surgical Staplers and Staples, Which May Prompt Various Recalls Surgical staplers and staples are used for a variety of reasons, both internally and externally. Examples of such uses include, among others, wound closure (typically with scalp or trunk of the body), removal (resection) of … [Read more...] about FDA to Reclassify Surgical Staplers and Staples
Ethicon Recalls Over 90,000 Defective Surgical Staplers
UNITED STATES – Certain surgical staplers manufactured by Ethicon have been recalled due to mounting complications. The U.S. Food and Drug Administration has announced that two kinds of surgical staplers used in gastrointestinal surgeries are part of a Class I recall. A Class I recall is the highest level with the FDA, and it … [Read more...] about Ethicon Recalls Over 90,000 Defective Surgical Staplers
Surgical Stapler Reclassification Data Skewed By Hidden FDA Reports
The United States Food and Drug Administration (FDA) holds the responsibility of ensuring that medical devices and products are safe for consumer use. When a product malfunctions, the FDA’s MAUDE database is meant to receive submissions of product malfunction. Recently, however, in the midst of the surgical stapler reclassification … [Read more...] about Surgical Stapler Reclassification Data Skewed By Hidden FDA Reports
Injuries Associated with Surgical Staplers
UNITED STATES – As reported online by www.physiciansweekly.com, the United States Food and Drug Administration (FDA) announced new steps to help reduce the risk of patient injury and death associated with surgical staplers. In March of 2019, the FDA sent a letter to healthcare providers notifying them of an increasing number of … [Read more...] about Injuries Associated with Surgical Staplers
J&J Initiates Corrective Action for Surgical Staplers
Medical device and pharmaceutical giant Johnson & Johnson, by way of its subsidiary Ethicon Endo-Surgery, LLC, has initiated a corrective action for certain surgical staplers in Europe, the Middle East, and Africa. The corporation has publicly released a notice indicating that its Intramural Staplers are prone to issues with … [Read more...] about J&J Initiates Corrective Action for Surgical Staplers
Ethicon Intraluminal Stapler Notice Issued In Several Regions
Surgical staples are a near-universal feature of the modern operating room. Offering faster and quicker application than more traditional methods, the staples are marketed and largely perceived as a more efficient and reliable method of post-op wound closure than the precise and honed craft of stitching a patient. Yet for all its … [Read more...] about Ethicon Intraluminal Stapler Notice Issued In Several Regions
Surgical Stapling Risks Hidden from Public View
A report from Kaiser Health News reveals that a large number of complications from surgical stapling devices have been filed in a database that is hidden from public view. By using a loophole in reporting to the U.S. Food and Drug Administration, the manufacturers of surgical staplers have been able to keep risk information away from … [Read more...] about Surgical Stapling Risks Hidden from Public View
FDA Surgical Stapler Risks Letter to Healthcare Providers
The U.S. Food and Drug Administration sent a letter to healthcare providers on March 8, 2019 alerting them to identified risks of surgical staplers and implantable staples. The FDA stated in the letter that it was receiving a rising number of adverse event reports on the devices and that it planned to create new labeling guidance and … [Read more...] about FDA Surgical Stapler Risks Letter to Healthcare Providers
Surgical Stapler and Implantable Staple Complications Top 40,000
The U.S. Food and Drug Administration has announced that it has identified more than 40,000 reports of complications for surgical staplers and implantable staples. The agency published this information in a public release on March 8, as well as in a letter sent to medical providers the same day. A growing number of adverse events … [Read more...] about Surgical Stapler and Implantable Staple Complications Top 40,000
FDA Warns of Risks With Surgical Staplers and Implantable Staples
On March 8, 2019, the U.S. Food and Drug Administration published a release regarding the risks associated with surgical staplers and implantable staples. The release states that the FDA has become aware of rising numbers of medical device reports regarding these two devices and that the agency sent communication to health care … [Read more...] about FDA Warns of Risks With Surgical Staplers and Implantable Staples
Tyco US Surgical Stapler Side Effects
A review by the Food and Drug Administration has linked 112 deaths and 2,180 injuries to surgical staplers. In many cases, the staples failed to close around the patient's tissue or the stapler failed to release the staples resulting in leakage. Among the patients who died, the stapled tissue typically had begun leaking fluid or … [Read more...] about Tyco US Surgical Stapler Side Effects
Ethicon Stapler Side Effects May Be Linked To Personal Injury Lawsuits
Ethicon Stapler Injury Lawyers Our firm is investigating injuries caused by Ethicon Endo-Surgery, Inc’s gastric bypass stapler. If you or a loved one experienced staple line disruption, infection or other serious complications following gastric bypass surgery, an Ethicon Stapler could be to blame. You may be entitled to compensation … [Read more...] about Ethicon Stapler Side Effects May Be Linked To Personal Injury Lawsuits
Big Chance: Widow Makes Gastric Bypass Plea
A Massive Infection Over Gastric Bypass Surgery. Mark Gratta looked the picture of health when he played on the Hingham High School football team 28 years ago. I remember thinking, ˜He's so handsome and in such good shape,''' said Louise Gratta, who is now his widow. Few people knew the truth. ˜He was dieting even … [Read more...] about Big Chance: Widow Makes Gastric Bypass Plea
112 Deaths Linked To Surgical Staplers
Staples failed to close around the patient’s tissue, the apparent problem in the Brigham case. A review by the Food and Drug Administration has linked 112 deaths and 2,180 injuries to surgical staplers, the same device implicated in the death of a Lawrence woman after gastric bypass surgery last month at Brigham and Women's … [Read more...] about 112 Deaths Linked To Surgical Staplers
