BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP PROBE,ABC,5 MM,F/S,DISP

    MDR report key: 12375632 · Received August 26, 2021

    Report

    Report Number
    3007305485-2021-00347
    Event Type
    Injury
    Date Received
    August 26, 2021
    Date of Event
    July 27, 2021
    Report Date
    September 29, 2021
    Product Code
    GEI
    PMA / PMN Number
    K925903
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D4: THE LOT NUMBER 202004074 WAS PROVIDED BY THE FACILITY; HOWEVER, IT CANNOT BE VERIFIED IN CONMED'S DATA BASE. MANUFACTURER NARRATIVE: REPORTED EVENT IS CONFIRMED. ONE 160655 RETURNED OPENED IN UNORIGINAL PACKAGING. THE LOT NUMBER OF THE DEVICE WAS NOT VERIFIED. A VISUAL INSPECTION FOUND THE TIP OF THE PROBE WAS DAMAGED. TWO PIECES WERE RETURNED, ONE WHITE PIECE OF MATERIAL FROM THE INNER SHAFT AND ONE PIECE FROM THE OUTER BLACK SHAFT. A TWO-YEAR LOT HISTORY REVIEW SHOWS THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT VERIFIED. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 7 COMPLAINTS, REGARDING 7 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME 205,960 DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE 0.00003. PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: REMOVE TIP PROTECTOR FROM END OF PROBE PRIOR TO USE. INSPECT THE PROBE FOR ANY DAMAGE. DO NOT USE IF YOU SUSPECT ANY DAMAGE IS PRESENT. NOTIFY THE MANUFACTURER IMMEDIATELY. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE,160655, WAS BEING USED ON (B)(6) 2021 DURING A LAPAROSCOPIC HEPATIC LEFT LATERAL SEGMENTECTOMY PROCEDURE AND THE TIP ON THE LAPAROSCOPIC ARGON HANDPIECE BROKE OFF. AFTER FURTHER ASSESSMENT IT WAS FOUND, THAT IT IS NOT KNOWN IF ALL FRAGMENTS WERE RETRIEVED. THE ELECTRO SURGICAL UNIT MODEL WAS A 60-8800-001 SERIAL # (B)(6) AND THE SETTINGS WERE 120 LAPAROSCOPIC. THE 60-8800-001 WILL BE LISTED AS A CONCOMITANT DEVICE. THE PROCEDURE WAS COMPLETED. THERE WAS A 30 MINUTE DELAY.15 MINUTES SEARCHING THE ABDOMEN FOR FRAGMENTS OF TIP. ANOTHER 15 MINUTES WAITING FOR X-RAY TO DETERMINE IF FRAGMENTS WOULD BE X-RAY DETECTABLE (THEY WERE NOT). THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO POSSIBLE FRAGMENTS REMAINING IN PATIENT.

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE HAS BEEN RETURNED TO CONMED; HOWEVER, THE EVALUATION OF THE DEVICE HAS NOT BEEN COMPLETED. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 160655, WAS BEING USED ON (B)(6) 2021 DURING A LAPAROSCOPIC HEPATIC LEFT LATERAL SEGMENTECTOMY PROCEDURE AND THE TIP ON THE LAPAROSCOPIC ARGON HANDPIECE BROKE OFF. AFTER FURTHER ASSESSMENT IT WAS FOUND, THAT IT IS NOT KNOWN IF ALL FRAGMENTS WERE RETRIEVED. THE ELECTRO SURGICAL UNIT MODEL WAS A 60-8800-001 SERIAL # (B)(4) AND THE SETTINGS WERE 120 LAPAROSCOPIC. THE 60-8800-001 WILL BE LISTED AS A CONCOMITANT DEVICE. THE PROCEDURE WAS COMPLETED. THERE WAS A 30 MINUTE DELAY. 15 MINUTES SEARCHING THE ABDOMEN FOR FRAGMENTS OF TIP. ANOTHER 15 MINUTES WAITING FOR X-RAY TO DETERMINE IF FRAGMENTS WOULD BE X-RAY DETECTABLE (THEY WERE NOT). THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO POSSIBLE FRAGMENTS REMAINING IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271582 LAP PROBE,ABC,5 MM,F/S,DISP ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI 202004074

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other 60-8800-001 ELECTRO SURGICAL UNIT| 60-8800-001 ELECTRO SURGICAL UNIT| X-RAY| X-RAY| 60-8800-001 ELECTRO SURGICAL UNIT| X-RAY