CONMED
Report
- Report Number
- 1320894-2025-00283
- Event Type
- Malfunction
- Date Received
- December 16, 2025
- Date of Event
- November 28, 2025
- Report Date
- January 27, 2026
- Manufacturer
- CONMED
- Product Code
- GEI
- UDI-DI
- 10653405004974
- PMA / PMN Number
- K153499
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE REPORTED DEVICE IS BEING RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY. H3 OTHER TEXT: DEVICE NOT YET RECEIVED.
EXAMINATION OF THE RETURNED USED DEVICE, ITEM AES-50SL FOUND ELECTRODE TIP DETACHED, BROKEN OFF FROM THE DEVICE SHAFT. EXAMINATION WAS PERFORMED BY EDGE PROBES, STANDARD WORK LINE #1, MP-09-1770, REV AV. A ROOT CAUSE CANNOT BE DETERMINED; HOWEVER, BASED UPON EVALUATION OF THE DEVICE, A POSSIBLE CAUSE OF THIS EVENT COULD BE USE OF EXCESSIVE FORCE. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED TO NOT USE THE PROBE FOR MECHANICAL DISPLACEMENT OF TISSUE, DAMAGE TO THE PROBE MAY OCCUR. DO NOT ACTIVATE THE PROBE WHILE ANY PORTION OF THE ACTIVE OR RETURN ELECTRODE IS IN CONTACT WITH ANOTHER METAL OBJECT, INCLUDING THE SCOPE; LOCALIZED HEATING OF THE ELECTRODE AND THE ADJACENT METAL OBJECT MAY RESULT IN PRODUCT DAMAGE AND/OR INJURY. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, AES-50SL, ARTHROSCOPIC ENERGY 50° PROBE WITH SUCTION, XL, 18 CM, WAS BEING USED DURING A HIP ARTHROSCOPY PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿DURING THE SURGERY, THE SURGEON USED THE BIPOLAR DEVICE, AND THE BLACK TIP OF THE ELECTRODE DETACHED FROM THE DEVICE¿S TIP WHEN IT WAS REMOVED FROM THE TROCAR.¿. FURTHER ASSESSMENT WAS REQUESTED FROM THE REPORTER AND THEY STATED, ¿IT BROKE INSIDE THE PATIENT, AND THE BREAK WAS VISUALIZED THROUGH THE CAMERA. THE TIP WAS DAMAGED BUT STILL ATTACHED TO THE HANDLE. ONCE THE INSTRUMENT WAS REMOVED FROM THE PATIENT, THE TIP FELL ONTO THE FLOOR.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A 2-MINUTE DELAY WITHOUT AN ALTERNATE DEVICE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, AES-50SL, ARTHROSCOPIC ENERGY 50° PROBE WITH SUCTION, XL, 18 CM, WAS BEING USED DURING A HIP ARTHROSCOPY PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿DURING THE SURGERY, THE SURGEON USED THE BIPOLAR DEVICE, AND THE BLACK TIP OF THE ELECTRODE DETACHED FROM THE DEVICE¿S TIP WHEN IT WAS REMOVED FROM THE TROCAR.¿. FURTHER ASSESSMENT WAS REQUESTED FROM THE REPORTER AND THEY STATED, ¿IT BROKE INSIDE THE PATIENT, AND THE BREAK WAS VISUALIZED THROUGH THE CAMERA. THE TIP WAS DAMAGED BUT STILL ATTACHED TO THE HANDLE. ONCE THE INSTRUMENT WAS REMOVED FROM THE PATIENT, THE TIP FELL ONTO THE FLOOR.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A 2-MINUTE DELAY WITHOUT AN ALTERNATE DEVICE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2257125 | CONMED | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | CONMED | 202509041 | 10653405004974 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |