BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6" INCH BEND A BEAM MALABLE ABC HANDPIECE

    MDR report key: 8065545 · Received November 13, 2018

    Report

    Report Number
    3007305485-2018-00252
    Event Type
    Malfunction
    Date Received
    November 13, 2018
    Date of Event
    July 3, 2018
    Report Date
    December 20, 2018
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT
    Product Code
    GEI
    UDI-DI
    00653405002751
    PMA / PMN Number
    K961505
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALLEGED 134006, ARGON BEAM HANDPIECE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED. THIS COMPLAINT OF "SHOOTING FLAMES" IS UNABLE TO BE VERIFIED AND A ROOT CAUSE CANNOT BE DETERMINED. A REVIEW OF THE MANUFACTURING DOCUMENTS FROM THE DHR HAS VERIFIED THE DEVICES WERE PRODUCED ACCORDING TO CURRENT AND APPROVED PROCEDURES AND MATERIAL SPECIFICATIONS. NON-CONFORMANCES REGARDING THE PRODUCT'S IDENTITY, QUALITY, SAFETY, EFFECTIVENESS OR PERFORMANCE WERE NOT IDENTIFIED DURING MANUFACTURE. A TWO-YEAR LOT HISTORY REVIEW WAS CONDUCTED AND THERE HAVE BEEN NO OTHER SIMILAR COMPLAINTS FOR THIS LOT OF PRODUCT. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 6 COMPLAINTS, REGARDING 6 DEVICES FOR THIS FAMILY AND FAILURE MODE. DURING THE 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: 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 USE THE SHORTEST EFFECTIVE ABC ACTIVATION TIME NECESSARY USE THE LOWEST POSSIBLE POWER SETTING ON THE CONMED ABC ELECTROSURGICAL GENERATOR CAPABLE OF ACHIEVING THE DESIRED SURGICAL EFFECT. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED VIA MEDWATCH # (B)(4) ON 11-27-2018. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    PER THE ATTENDING SURGEON THE 134006 ARGON BEAM HANDPIECE BEGAN SHOOTING FLAMES AND A NEW HANDPIECE NEEDED TO BE USED. THIS REPORT WAS RECEIVED OFF THE MAUDE DATABASE. THERE IS NO OTHER ADDITIONAL INFORMATION AVAILABLE. THIS REPORT IS BEING RAISED ON THE BASIS OF DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON "REOCCURENCE".

    Description of Event or Problem · 1

    ON NOVEMBER 27, 2018 ADDITIONAL INFORMATION WAS PROVIDED VIA A MEDWATCH REPORT, REPORT NUMBER (B)(4). THE FACILITY STATED THE PROCEDURES BEING PERFORMED WERE (1) OPEN LEFT NEPHRECTOMY, (2) REMOVAL OF MIGRATED LEFT RENAL VEIN STENT FROM THE IVC, (3) CAVOPLASTY, (4) BACK TABLE PREPARATION OF LEFT RENAL AUTOGRAFT, (5) TRANSPLANT OF LEFT RENAL AUTOGRAFT INTO RIGHT ILIAC FOSSA, (6) URETERONEOCYSTOSTOMY AND (7) PLACEMENT OF CYSTO-URETERAL STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904269 6" INCH BEND A BEAM MALABLE ABC HANDPIECE ARGON BEAM HANDPIECE GEI CONSOLIDATED MEDICAL EQUIPMENT 201801224 00653405002751

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR