miércoles, 30 de octubre de 2019

FDA MedWatch~ECHELON FLEX ENDOPATH Staplers by Ethicon: Class I Recall

A MedWatch Safety Alert was added to the FDA Medical Device Recalls webpage. 

TOPIC: ECHELON FLEX ENDOPATH Staplers by Ethicon: Class I Recall - Due to Failure to Completely Form Staples

AUDIENCE: Surgery, Health Professional, Risk Manager

ISSUE: Ethicon is recalling these devices because some devices may contain an out of specification component within the jaw of the device, which could lead to malformed staples. If a problem with the staple line is not recognized or is not adequately addressed, there is a potential risk of prolonged surgery, postoperative connection (anastomotic) leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death. As of October 3, 2019, 7 serious injuries and 1 death had been reported to Ethicon for affected product codes.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
  • Complete and submit the report online.
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.

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