CONMED SB534Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04714127860664), received between Jun 15, 2020 and Jun 10, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2026Break

  THE BAG RIPPED AT THE BOTTOM WITHOUT ANY INSTRUMENTS PIERCING IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25454097 ↗
• MalfunctionJan 29, 2026Break

  THE RETRIEVAL BAG BEING USED TO OBTAIN APPENDIX IN A LAP APPY CASE. BAG BROKE OPEN WHEN TRYING TO REMOVE THE SPECIMEN. TRIED WITH A NEW BAG AND HAPPENED AGAIN. SPECIMEN WAS REMOVED BY SURGICAL INSTRUMENT FROM ABDOMEN BY DOCTOR AFTER THE BAGS FAILED. SURGICAL TEAM EXAMINED SPECIMEN BAG, DID NOT APPEAR TO BE MISSING ANY PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24207328 ↗
• MalfunctionNov 11, 2025Break; Break

  THE 5MM BAG RIPPED WHILE TRYING TO GET THE SPECIMEN OUT. THE DEVICE WAS USED IN A LAPAROSCOPIC CHOLECYSTECTOMY WHICH WAS COMPLETED WITHOUT ANY REPORT OF DELAY. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23519966 ↗
• MalfunctionJun 15, 2020Material Fragmentation; Material Fragmentation

  VOLUNTARY DISTRIBUTOR REPORT: ON BEHALF OF THE CUSTOMER, THE CONMED REPRESENTATIVE REPORTED ISSUES WITH THE 3X4 MINI ENDO POCKET BAG, ITEM SB534, LOT 6251903128. IT WAS REPORTED ONLY THAT A PIECE OF PLASTIC BREAKS OFF AND FALLS INTO THE PATIENT WHEN THE BAG IS BEING DEPLOYED. ADDITIONAL INFORMATION PROVIDED INDICATES THE ISSUE OCCURRED ON (B)(6) 2020 DURING A ROBOTIC CHOLECYSTECTOMY. WHILE THE SPECIMEN WAS BEING REMOVED THROUGH THE INCISION, THE PLASTIC PIECE SPLINTERED EITHER DURING OR JUST AFTER THE REMOVAL OF THE SPECIMEN. IT WAS CLARIFIED THAT THE PIECE IN QUESTION NEVER BROKE OR FELL INSIDE THE PATIENT. THERE WAS NO IMPACT OR INJURY TO THE PATIENT, NO INDICATION OF THE SPECIMEN FALLING OUT OR FRAGMENTATION OF THE BAG. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE DEVICE IN QUESTION WAS DISCARDED. THE SIZE OF THE TROCAR IS UNKNOWN AND STANDARD ROBOTIC INSTRUMENTS LIKE A GRASPER WERE BEING USED AT THE TIME. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10153859 ↗