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 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
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
