BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TC DE'BAKEY NEEDLE HOLDERDELSERR165MM

    MDR report key: 4269446 · Received October 15, 2014

    Report

    Report Number
    2916714-2014-00786
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    July 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    HXK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTRING SITE EVALUATION: WAITING FOR PRODUCT RETURN.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). AT THE END OF A HERNIA SURGERY, WHEN CLOSING THE INCISION, THE NEEDLE DROPPED. AFTER CHECKING, IT WAS FOUND THAT ONE TIP OF THE NEEDLE HOLDER FRACTURED AND THE FRACTURED PARTS WERE MISSING. FOR 2 HOURS THE SURGEON AND NURSE MADE ATTEMPTS TO LOCATE THE MISSING PART USING MAGNET AND C-ARM X-RAY MACHINE; THE MISSING PIECE WAS NOT FOUND. SURGEON HAD TO CLOSE INCISION AND END THE SURGERY AND WAS NOT FOR SURE IF THE BROKEN PART REMAINED IN THE PATIENT. PATIENT'S HOSPITALIZATION WAS PROLONGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652804 TC DE'BAKEY NEEDLE HOLDERDELSERR165MM HXK AESCULAP AG & CO. KG BM033R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other