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 means that the included products can result in severe injuries or death. Two kinds of surgical staplers manufactured by Ethicon, including the Endo-Surgery Endoscopic Curved Intraluminal Stapler and Endo-Surgery Curved Stapler, are part of a Class I recall due to the potential that the staplers can misfire and release malformed staples. These are both circular staplers.
This recall began in April 2019 and applies to almost 92,500 staplers that were manufactured from March 2018 to March 2019. The staplers were also distributed from March 2018 to March 2019. The FDA says the possibility for defects in the staplers continued until a shifted manufacturing line closed at the beginning of March 2019.
Misfired staples or malformed staples can result in serious injuries to patients, according to the FDA, which include:
- Weakening of the staple line;
- Leaking in the staple closures;
- Need for additional stapling or surgeries;
- Permanent digestive problems;
- Permanent nutritional problems;
- Need for an ostomy bag; and
Ethicon confirms that two patients had serious injuries result from misfired staplers. Both instances involved surgeries to remove the upper rectum, and the misfiring resulted in the patients having to have more of the rectum removed. Patients who have experienced adverse events associated with Ethicon staplers or any other brand of surgical stapler can report the events to the FDA online.
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