BEUDAMED
    FDA Adverse Event Other Summary report: N

    RENEW L HOOK TIP

    MDR report key: 3284598 · Received August 2, 2013

    Report

    Report Number
    1223422-2013-00028
    Event Type
    Other
    Date Received
    August 2, 2013
    Report Date
    August 2, 2013
    Manufacturer
    MICROLINE SURGICAL
    Product Code
    GEI
    PMA / PMN Number
    K981188
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE REF (B)(4) PROBE AND ONE REF (B)(4) TIP WERE RETURNED, DECONTAMINATED AND INVESTIGATED. AMN INSPECTION OF THE RETURNED PROBE WITH THE TIP WAS PERFORMED. IT WAS OBSERVED THAT THE TUBE END MADE FROM BLUE RADEL IS BROKEN SLIGHTLY INSIDE AT THE END OF THE BLACK INSULATION TUBE. THE BROKEN END OF THE BLUE RADEL SHAFT IS THREADED PROPERLY INSIDE OF THE L-HOOK CAUTERY TIP. THE BROKEN END WAS REMOVED FROM THE CAUTERY TIP WITHOUT DIFFICULTY AND IT WAS FOUND TO BE IN GOOD CONDITION. THE WHITE MARKER BAND WAS PRESENT. THE WIRE ON THE RETURNED TIP HAS TWO BENDS AT THE BROKEN AREA OF THE SHAFT, INDICATING THAT A STRONG SIDE LOAD WAS APPLIED. THE PROBE SHAFT HAS A DENT ON THE INNER DIAMETER AT THE BENT CAUTERY TIP LOCATION WHICH IS FROM LATERAL FORCES BEING APPLIED TO THE TIP RESULTING IN THE FAILURE. THIS TYPE OF FAILURE IS NOT CONSISTENT WITH NORMAL USE.

    Description of Event or Problem · 1

    THE L-HOOK TIP BROKE OFF OF THE PROBE HANDPIECE LEAVING A SHARP PART TO BE TAKEN OUT OF THE PATIENT'S ABDOMEN. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363987 RENEW L HOOK TIP CAUTERY PROBE GEI MICROLINE SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) CAUTERY PROBE 34CM| (B)(4) DISPOSABLE L-HOOK TIP,LOT NUMBER 00111851| LOT NUMBER 00108547 AND S/N (B)(4)| MANUFACTURING DATE 04/24/2012| EXPIRY DATE 03/2014, MANUFACTURING DATE 03/25/2013