AES-90SN PROBE ASSY,SUCT,SIN
Report
- Report Number
- 1320894-2023-00200
- Event Type
- Malfunction
- Date Received
- October 4, 2023
- Date of Event
- September 14, 2023
- Report Date
- November 6, 2023
- Manufacturer
- CONMED UTICA
- Product Code
- GEI
- UDI-DI
- 20653405006470
- PMA / PMN Number
- K153499
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
EXAMINATION OF THE RETURNED USED DEVICE FOUND THE ELECTRODE DETACHED FROM THE PROBE TIP. DETACHED ELECTRODE WAS NOT RETURNED PER EVALUATION. EXAMINATION PERFORMED PER EDGE PROBES, STANDARD WORK LINE #1, MP-09-1770. A LIKELY CAUSE FOR THIS ISSUE IS THE PROBE CONTACTING OTHER METALLIC OBJECT DURING THE PROCEDURE AND/ OR UTILIZATION OF HIGH POWER AND LONGER-THAN-RECOMMENDED ACTIVATION TIMES. 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 THAT IF ANY VISUAL DAMAGE OR DEFECTS ARE NOTICED DURING USE, STOP USING THE DEVICE IMMEDIATELY AND REPLACE THE DEVICE. DO 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. THE IFU ALSO ADVISES THE USER TO USE CAUTION WHEN CHANGING POWER SETTINGS. USE THE LOWEST POWER SETTING AND THE MINIMUM TISSUE CONTACT-TIME NECESSARY TO ACHIEVE THE APPROPRIATE SURGICAL EFFECT. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.
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 FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY. H3 OTHER TEXT: DEVICE NOT YET RECEIVED.
THE CUSTOMER REPORTED THAT THE DEVICE, AES-90SN, AES-90SN PROBE ASSY, SUCT, SIN, WAS TO BE USED DURING AN ACL PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED, ¿ACL CASE ON (B)(6) AT (HOSPITAL). AFTER TAKING THE AES-90SN OUT OF THE PACKAGING, MY TEAM SAW MISSING PROBE TIP, WE HAD TO USE A NEW WAND TO USE FOR THE ACL CASE". THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE, SAME-LIKE DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
THE CUSTOMER REPORTED THAT THE DEVICE, AES-90SN, AES-90SN PROBE ASSY,SUCT,SIN, WAS TO BE USED DURING AN ACL PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED, ¿ACL CASE ON SEPTEMBER 14TH AT (HOSPITAL). AFTER TAKING THE AES-90SN OUT OF THE PACKAGING, MY TEAM SAW MISSING PROBE TIP¿¿. WE HAD TO USE A NEW WAND TO USE FOR THE ACL CASE.¿. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE, SAME-LIKE DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. 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 |
|---|---|---|---|---|---|---|---|
| 1485664 | AES-90SN PROBE ASSY,SUCT,SIN | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | CONMED UTICA | 202304111 | 20653405006470 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |