BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDRIVE ULTRA POWERED HANDLE 2

    MDR report key: 5754571 · Received June 28, 2016

    Report

    Report Number
    1219930-2016-00648
    Event Type
    Malfunction
    Date Received
    June 28, 2016
    Date of Event
    May 31, 2016
    Report Date
    June 1, 2016
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GDW
    PMA / PMN Number
    K121510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY PENDING INVESTIGATION CONCLUSION.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HAS NOT BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SENT IF DEVICE IS RECEIVED.

    Additional Manufacturer Narrative · 1

    FTR# (B)(4). EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION ONE POWERED HANDLE, ONE ADAPTER, AND ONE BATTERY PACK. THIS EVALUATION WAS BASED ON A TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, A PMV REVIEW OF COMPLAINT TRENDS, AND AN EVALUATION OF THE RETURNED DEVICE. THE BATTERY WAS INSPECTED AND NO RESIDUE OR SUBSTRATE WAS FOUND ON THE LEADS. NO DAMAGE WAS NOTED TO THE BATTERY. MICROSCOPIC EVALUATION OF THE ADAPTER REVEALED 2 CRACKED SOLDER JOINTS. THE BATTERY TESTED SATISFACTORILY IN A PMV HANDLE AND ADAPTER. THE HANDLE TESTED SATISFACTORILY. A PMV LOADING UNIT WAS INSERTED ONTO THE ADAPTER IN THE RETURNED HANDLE AND RELOAD RECOGNITION WAS INCONSISTENT. WHEN THE RELOAD WAS RECOGNIZED, THE ADAPTER LOST CONNECTION AND THE RELOAD BEGAN ARTICULATING UNCONTROLLABLY DURING ROTATION. THE ADAPTER WAS THEN TESTED IN A PMV HANDLE AND RELOAD RECOGNITION WAS AGAIN INCONSISTENT. UNCONTROLLED ARTICULATION OCCURS WHEN THE ADAPTER LOSES RECOGNITION OF THE RELOAD AND BEGINS CALIBRATING WHILE THE RELOAD IS ATTACHED. INCONSISTENT RELOAD RECOGNITION CAN BE CAUSED BY A MALFUNCTIONING SWITCH. A MALFUNCTIONING SWITCH IS THE RESULT OF COMPROMISED SOLDER JOINTS. A MANUFACTURING ENHANCEMENT HAS BEEN IMPLEMENTED TO PREVENT THIS CONDITION FROM RECURRING. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, WHEN THE SURGEON APPROACHED THE TISSUE, THE DEVICE STARTED THE SELF CHECK ON ITS OWN AND THE RELOAD INDICATOR TURNED OFF. THE JAWS OF THE RELOAD WOULD NOT CLOSE, AND THE DEVICE WAS THEREFORE REMOVED FROM THE CAVITY WITH THE JAWS REMAINING OPENED. AFTER REATTACHING THE ADAPTER AND RELOAD, THE SURGEON ATTEMPTED TO APPROACH THE TISSUE ONCE AGAIN, HOWEVER, THE SELF CHECK BEGAN AGAIN THE JAWS ARTICULATED, AND THE RELOAD INDICATOR TURNED OFF. A MANUAL HANDLE WAS USED TO CONTINUE THE CASE. IT IS UNKNOWN IF REINFORCEMENT MATERIAL WAS USED. THERE WAS NO UNANTICIPATED TISSUE LOSS. NOTHING FELL INTO THE CAVITY. THERE WAS NO IRREVERSIBLE TISSUE DAMAGE. THERE WAS NO UNANTICIPATED EXTENSION FOR THE INCISION MORE THAN ONE INCH. THERE WAS NO UNANTICIPATED BLOOD LOSS OF MORE THAN 500CC. SURGERY TIME WAS NOT DELAYED BY MORE THAN 30 MINUTES. THE LAST KNOWN PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410122 IDRIVE ULTRA POWERED HANDLE 2 STAPLE, IMPLANTABLE GDW COVIDIEN, FORMERLY US SURGICAL A DIVISON IDRVULTRA2 N4K1062LX

    Patients

    Seq Age Sex Outcome Treatment
    1