BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6" BEND-A-BEAM MALABLE ABC HP

    MDR report key: 8018791 · Received October 30, 2018

    Report

    Report Number
    3007305485-2018-00231
    Event Type
    Malfunction
    Date Received
    October 30, 2018
    Date of Event
    October 8, 2018
    Report Date
    October 30, 2018
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT
    Product Code
    GEI
    UDI-DI
    00653405002751
    PMA / PMN Number
    K961505
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE 134006 WAS RECEIVED IN OPENED ORIGINAL PACKAGING, THE REPORTED CATALOG AND LOT NUMBERS WERE VERIFIED. INSPECTION FOUND THAT THE DISTAL TIP OF THE DEVICE APPEARED MELTED. THE DEVICE WAS TESTED WITH A SYSTEM 7500 ESU (C6639). TESTING FOUND THAT THE DEVICE FUNCTIONED AS EXPECTED AND NO SPARK OR FLAME WERE OBSERVED. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD (DHR) HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. A REVIEW OF THE DHR FOUND NO ABNORMALITIES THAT WOULD CONTRIBUTE TO THIS ISSUE AND THE PRODUCT RELEASED FOR DISTRIBUTION WERE 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 14 COMPLAINTS, REGARDING 17 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: USE THE LOWEST POSSIBLE POWER SETTING ON THE CONMED ABC ELECTROSURGICAL GENERATOR CAPABLE OF ACHIEVING THE DESIRED SURGICAL EFFECTS. USE THE SHORTEST EFFECTIVE ABC ACTIVATION TIME NECESSARY. THESE DEVICES SHOULD BE INSPECTED BEFORE USE. VISUALLY EXAMINE THE DEVICES FOR OBVIOUS PHYSICAL DAMAGE AND DO NOT USE IF FOUND: CRACKED, BROKEN OR OTHERWISE DISTORTED PLASTIC PARTS; BROKEN OR SIGNIFICANTLY BENT HANDLE, SHAFT OR CONNECTOR CONTACTS. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ISSUE WITH THE 134006, 6" BEND-A-BEAM MALABLE ABC (ARGON BEAM COAGULATOR) HP (HANDPIECE) DEVICE. IT WAS REPORTED THAT THE SURGEON WAS HOLDING HAND PIECE ABOVE ABDOMEN WHEN A SPARK OCCURRED AT DISTAL END THAN A FLAME. THE PRODUCT WAS SUBMERGED IN WATER AND UNIT WAS UNPLUGGED. THERE WAS NO REPORTED INJURY OR IMPACT TO THE PATIENT OR USER. ADDITIONAL INFORMATION OBTAINED INDICATES THAT THE ISSUE OCCURRED AT THE END OF THE GYNONC DEBULKING PART OF THE PROCEDURE. THE DEVICE WAS IN THE SURGEON'S HAND ABOVE AND PERPENDICULAR TO THE PATIENT WHEN THE SPARK OCCURRED AND IMMEDIATELY THE FLAME WAS NOTED. THE HEAT MELTED THE PLASTIC COVERING ON THE TIP. THE HANDPIECE WAS IMMEDIATELY SUBMERGED INTO WATER. IT IS INDICATED THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861032 6" BEND-A-BEAM MALABLE ABC HP ELECTROSURGICAL HANDPEICE GEI CONSOLIDATED MEDICAL EQUIPMENT 201605164 00653405002751

    Patients

    Seq Age Sex Outcome Treatment
    1