GeniSurge 533-005-945TRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00877972006916), received between Aug 10, 2020 and Aug 16, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (2 reports).

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.

• MalfunctionAug 16, 2020Mechanical Problem; Mechanical Problem

  A FAULTY ENDOCLINCH PRODUCT, 1 533-005-945 OPENED YESTERDAY IN THE THEATRE, WHICH FELL APART ON INSERTION INTO THE ABDOMEN, THE PARTS WERE SUCCESSFULLY RETRIEVED AND A DATIX COMPLETED. ITEM WAS ISOLATED FOR EXAMINATION, ALL OTHER ITEMS FROM THAT BATCH WERE REMOVED FROM STORE AND ARE IN THE THEATRE CONTROLLER'S OFFICE AWAITING FURTHER ADVICE, IT WAS A LAP COLORECTAL PROCEDURE, IT HAPPENED WITH 2 OF THE CLINCHES FROM THE SAME LOT, ONLY ONE RETURNED AS THE OTHER WAS CONTAMINATED. NO STAPLES OR CLIPS WERE IN THE WAY AT THE TIME, IT HAPPENED IMMEDIATELY AFTER THE INSTRUMENT WAS INSERTED IN TO THE ABDOMEN WHEN THEY OPENED THE JAWS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10411870 ↗
• MalfunctionAug 10, 2020Mechanical Problem; Mechanical Problem

  A FAULTY ENDOCLINCH PRODUCT, 1 533-005-945 OPENED YESTERDAY IN THE THEATRE, WHICH FELL APART ON INSERTION INTO THE ABDOMEN, THE PARTS WERE SUCCESSFULLY RETRIEVED AND A DATIX COMPLETED. ITEM WAS ISOLATED FOR EXAMINATION, ALL OTHER ITEMS FROM THAT BATCH WERE REMOVED FROM STORE AND ARE IN THE THEATRE CONTROLLER'S OFFICE AWAITING FURTHER ADVICE, IT WAS A LAP COLORECTAL PROCEDURE, IT HAPPENED WITH 2 OF THE CLINCHES FROM THE SAME LOT, ONLY ONE RETURNED AS THE OTHER WAS CONTAMINATED. NO STAPLES OR CLIPS WERE IN THE WAY AT THE TIME, IT HAPPENED IMMEDIATELY AFTER THE INSTRUMENT WAS INSERTED INTO THE ABDOMEN WHEN THEY OPENED THE JAWS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10387825 ↗