CONMED 60-5163-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 30653405009768), received between Apr 16, 2024 and May 29, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (4 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 18, 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.

• MalfunctionMay 29, 2025Material Fragmentation; Melted; Overheating of Device; Material Fragmentation; Melted; Overheating of Device

  UPDATE: FURTHER ASSESSMENT INFORMATION REPORTED THAT "MELTED PLASTIC FELL INTO THE PATIENT WHEN IT MELTED OFF DURING USE. A LAPAROSCOPIC MARYLAND WAS USED TO PICK UP AND REMOVE THE MELTED PLASTIC". THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT 60-5163-001, LAPAROSCOPIC ELECTRODE WITH A 3/32" PIN CONNECTOR,L-HOOK DEVICE WAS BEING USED DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED ¿THE PLASTIC PART OF THE L-HOOK WAS MELTING.¿. FURTHER ASSESSMENT WAS ATTEMPTED, AND A GOOD FAITH EFFORT WAS COMPLETED, HOWEVER, TO DATE NO FURTHER INFORMATION IS AVAILABLE. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22110342 ↗
• MalfunctionMay 28, 2025Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 60-5163-001, LAPAROSCOPIC ELECTRODE WITH A 3/32" PIN CONNECTOR, L-HOOK, WAS BEING USED DURING AN OPEN PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿SING L-HOOK (SETTINGS AT 30CUT 30COAG BLEND) STAFF NOTICED SOME OF THE BLACK PLASTIC PART OF THE DEVICE HAD MELTED OFF IN BODY. MELTED PIECE AND L-HOOK REMOVED FROM BODY AND TAKEN OUT OF CIRCULATION.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22094820 ↗
• MalfunctionDec 10, 2024Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 60-5163-001, LAPAROSCOPIC ELECTRODE WITH A 3/32" PIN CONNECTOR,L-HOOK WAS BEING USED ON (B)(6) 2024 DURING A LAPAROSCOPIC PROCEDURE AND ¿THE COATING/INSULATION ON THE LHOOK HAD COME OFF.¿. PER FURTHER ASSESSMENT IT WAS FOUND THAT "NO FRAGMENT FELL INTO THE SURGICAL SITE.". THERE WAS NO IMPACT OR INJURY TO THE PATIENT. THERE WAS NO DELAY TO THE PROCEDURE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20891656 ↗
• InjuryApr 16, 2024Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE 60-5163-001, SOLID SHAFT ELECTRODE L HOOK 32CM, WAS BEING USED DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE ON (B)(6) 2024 DATE WHEN IT WAS REPORTED ¿SURGERY NOT DELAYED BUT INJURY TO PATIENT. SURGEON HAD TO USE LIGASURE TO REMOVE THE AFFECTED TISSUE FROM PATIENT BEFORE WE CONTINUED.¿. FURTHER ASSESSMENT QUESTIONING FOUND ¿THE PART OF SURGERY WHERE THE MALFUNCTION TOOK PLACE WAS THE COLPOTOMY. GREY PLASTIC FROM CAUTERY WAS ADHERED TO TISSUE INSIDE ABDOMEN. PLASTIC AND AFFECTED TISSUE WERE REMOVED FROM THE PATIENT.¿. THERE WAS A 5-MINUTE DELAY REPORTED AND THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS ¿UNSURE¿. THERE WAS NO REPORT OF MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE TO AFFECTED TISSUE REMOVED FROM THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 19116079 ↗