BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 15707473 · Received November 1, 2022

    Report

    Report Number
    3007305485-2022-00167
    Event Type
    Injury
    Date Received
    November 1, 2022
    Date of Event
    October 21, 2022
    Report Date
    January 3, 2023
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT COMPANY
    Product Code
    GEI
    PMA / PMN Number
    K925903
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    RECEIVED TWO DEVICES IN UNORIGINAL PACKAGE. LOT NUMBER NOT VERIFIED. PERFORMED A VISUAL INSPECTION, THE DEVICE CAME DISASSEMBLED AND DAMAGED INTO THREE FRAGMENTS. A DEVICE HISTORY RECORD REVIEW FOUND COULD NOT BE COMPLETED AS A LOT NUMBER WAS NOT PROVIDED. A TWO-YEAR LOT HISTORY REVIEW COULD NOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 7 REPORTS, REGARDING 7 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) 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 (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: THE USER IS ADVISED TO 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 160655, LAP PROBE,ABC,5 MM,F/S,DISP, WAS USED DURING A LAPAROSCOPIC SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED, ¿ONE OF OUR LAP PROBES BROKE OFF DURING A PROCEDURE AND THEY HAD TO RETRIEVE THE ITEM.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THE SURGERY WAS COMPLETED AND THE PATIENT WAS REPORTED TO BE HEALTHY. FURTHER ASSESSMENT QUESTIONING FOUND, "THE PATIENT HAD TO SWITCH FROM LAPAROSCOPIC TOO OPEN BECAUSE THE PATIENT WAS BLEEDING A LOT AND NOT BECAUSE THE PROBE BROKE IN THE PATIENT AND WHEN THEY SWITCHED TO OPEN THEY RETRIEVED THE FRAGMENTS OF THE PROBE." THE BROKEN PROBE WAS DISCOVERED UPON ITS REMOVAL. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO PROCEDURE BEING CHANGED FROM CLOSED TO OPEN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1512292 LAP PROBE,ABC,5 MM,F/S,DISP ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONSOLIDATED MEDICAL EQUIPMENT COMPANY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R