PROCINCH 234-102-065Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810020081978), received between Aug 4, 2022 and Sep 29, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Component Missing” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2023Component Missing; Component Missing

  ACCORDING TO THE REPORTER, "THE PROCINCH WAS MISSING THE GREEN AND GREEN WHITE SUTURES THAT LEAD AND TOGGLE THE BUTTON. WE OPENED TWO FREE SUTURES TO PASS THROUGH HOLES IN BUTTON WHERE SUTURES WERE MISSING IN ORDER TO COMPLETE THE PROCEDURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17843863 ↗
• MalfunctionAug 4, 2022Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  ACCORDING TO THE REPORTER, "THE PA CONSTRUCTED THE OPEN LOOP PROCINCH AT THE BACK TABLE FOLLOWING ALL MANUFACTURERS INSTRUCTIONS, AND WHEN THEY PULLED THE GRAFT DOWN AND AWAY FROM THE CARD, THE CINCHING MECHANISM WOULDN'T PULL INTO THE CENTER HOLES OF THE PROCINCH BUTTON. ONE OF THE LOOPS WAS THROUGH THE BUTTON, AND THE OTHER DID NOT PASS THROUGH ANY HOLES ON THE BUTTON. BOTH WHITE SUTURES CREATING LOOPS SHOULD BE THROUGH CENTER HOLES OF THE BUTTON."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15170607 ↗