BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY RECIPROCATOR II FOR BPL II

    MDR report key: 10033678 · Received May 7, 2020

    Report

    Report Number
    8030965-2020-03323
    Event Type
    Malfunction
    Date Received
    May 7, 2020
    Date of Event
    January 1, 2020
    Report Date
    March 5, 2020
    Manufacturer
    DEPUY SYNTHES PRODUCTS LLC
    Product Code
    GEY
    UDI-DI
    07611819491854
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS MEDWATCH, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED AS APPROPRIATE. DEVICE EVALUATION: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. DURING REPAIR, IT WAS DETERMINED THAT THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO COMPONENT FAILURE FROM NORMAL WEAR. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY. UDI: (01)07611819491854(21)101171.

    Description of Event or Problem · 1

    IT WAS REPORTED BY JAPAN THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY RECIPROCATOR DEVICE STOPPED BY ITSELF. IT WAS FURTHER DETERMINED THAT THE DEVICE HAD AN UNEXPECTED NOISE. IT WAS NOTED IN THE SERVICE ORDER THAT AN ELECTRIC SOUND WITH A BEEP OCCURRED WHEN THE MOTOR STOPPED WORKING. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2020. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497792 BATTERY RECIPROCATOR II FOR BPL II MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY DEPUY SYNTHES PRODUCTS LLC 07611819491854

    Patients

    Seq Age Sex Outcome Treatment
    1