BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP PROBE,5 MM, H/SWITCH,36CM

    MDR report key: 16870094 · Received May 4, 2023

    Report

    Report Number
    3007305485-2023-00100
    Event Type
    Malfunction
    Date Received
    May 4, 2023
    Date of Event
    April 17, 2023
    Report Date
    June 12, 2023
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT COMPANY
    Product Code
    GEI
    UDI-DI
    30653405003858
    PMA / PMN Number
    K925903
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    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. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY. H3 OTHER TEXT : DEVICE NOT YET RECEIVED.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT OF TIP CAME OFF IS CONFIRMED. RECEIVED ONE 160636 IN UNORIGINAL PACKAGE. LOT NUMBER WAS NOT VERIFIED. PERFORMED A VISUAL INSPECTION, THE COMPLAINT WAS CONFIRMED. THE TIP OF THE ABC PROBE CAME DISSEMBLED FROM THE REST OF THE DEVICE. ROOT CAUSE CANNOT BE DETERMINED, HOWEVER, BASED UPON EVALUATION OF THE DEVICE, REVIEW OF DRAWING, PHOTOS; POSSIBLE CAUSES OF THIS EVENT COULD BE EXCESSIVE FORCE OR USE OF A NON-CONMED DEVICE / COMPATIBLE CONSOLE. 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. 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 183,310 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 0.00004. 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. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT (B)(4) ON 26APR23. THE REPORT WAS FOUND TO BE WRITTEN AGAINST THE 160636, LAP PROBE,5 MM, H/SWITCH,36CM DEVICE THAT WAS BEING USED DURING A LAPAROSCOPIC LIVER CYST UNROOFING, PARTIAL HEPATECTOMY PROCEDURE ON (B)(6) 2023. THE REPORT STATED, ¿DURING LAPAROSCOPIC SURGERY THE TIP OF THE ABC PROBE CAME OFF. SURGEON WAS ABLE TO RETRIEVE THE PIECE AND DEVICE HAS BEEN SEQUESTERED. A NEW DEVICE WAS USED, AND THE CASE WAS ABLE TO BE COMPLETED WITHOUT FURTHER INCIDENT.¿ THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT 0700280000-2023-8012 ON 26APR23. THE REPORT WAS FOUND TO BE WRITTEN AGAINST THE 160636, LAP PROBE,5 MM, H/SWITCH,36CM DEVICE THAT WAS BEING USED DURING A LAPAROSCOPIC LIVER CYST UNROOFING, PARTIAL HEPATECTOMY PROCEDURE ON (B)(6) 2023. THE REPORT STATED, ¿DURING LAPAROSCOPIC SURGERY THE TIP OF THE ABC PROBE CAME OFF. SURGEON WAS ABLE TO RETRIEVE THE PIECE AND DEVICE HAS BEEN SEQUESTERED. A NEW DEVICE WAS USED, AND THE CASE WAS ABLE TO BE COMPLETED WITHOUT FURTHER INCIDENT.¿ THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715322 LAP PROBE,5 MM, H/SWITCH,36CM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONSOLIDATED MEDICAL EQUIPMENT COMPANY 202302014 30653405003858

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female