GEM VESSEL EVERTER GEM2742Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00844735006179), received between Dec 20, 2019 and Dec 20, 2019 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A BILATERAL DIEP (DEEP INFERIOR EPIGASTRIC PERFORATORS) PROCEDURE, IN WHICH COUPLER DEVICES WERE USED. IT WAS REPORTED THAT ON THE FIRST BREAST, DURING EVERSION OF VESSEL, THE RING WAS PUSHED OUT OF THE WING JAW ASSEMBLY. THE COUPLER SYSTEM WAS ABANDONED, AND THE VESSEL WAS ANATOMIZED WITH SUTURE. ON THE SECOND BREAST, A 2.0MM COUPLER WAS USED WITH APPROXIMATED 2.5MM INTERNAL MAMMARY ARTERY AND 2.0MM FLAP VESSEL, BOTH WERE EVERTED AND CLOSED WITH THE COUPLER SYSTEM. NO THROMBI WERE OBSERVED, HOWEVER, THE SURGEON REPORTED A WHITENING OF TISSUE AND DARKENING OF VEINS. IT WAS REPORTED A SIDE BRANCH WAS OPENED AND NO BLOOD FLOW WAS OBSERVED. THE COUPLER DEVICES WERE REMOVED, AND THE VESSELS WERE RE-ANATOMIZED WITH SUTURE. THE PATIENT OUTCOME WAS REPORTED AS ¿FINE¿. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Injury

  MAUDE report 9506240 ↗