BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SNOWDEN PENCER

    MDR report key: 4914923 · Received July 13, 2015

    Report

    Report Number
    1423714-2015-00002
    Event Type
    Malfunction
    Date Received
    July 13, 2015
    Date of Event
    April 9, 2015
    Report Date
    July 10, 2015
    Manufacturer
    ENDOPLUS, INC.
    Product Code
    HET
    PMA / PMN Number
    K925079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION REVEALS THAT THE DEVICE HAD BEEN MODIFIED BY A 3RD PARTY AS EVIDENCED BY A REPLACEMENT HANDLE SCREW WHICH DOD NOT MATCH ENDOPLUS SPECIFICATIONS. VISUAL EXAMINATION REVEALED THAT THE SURFACE OF THE HANDLED HAS BEEN MODIFIED. IN DOING SO, A 3RD PARTY APPEARS TO HAVE TAKEN STEPS TO PREVENT THE CATALOG NUMBER FROM BEING REMOVED BUT DID NOT TAKE STEPS TO PREVENT THE LOT CODE FROM BEING REMOVED. BECAUSE THE LOT CODE ON THE RETURNED DEVICE HAS BEEN REMOVED, THE EXACT MANUFACTURE DATE CANNOT BE VERIFIED. EXAMINATION UNDER MAGNIFICATION REVEALED THAT ONE JAW HAD BEEN TWISTED OFF AT THE PROXIMAL END OF THE JAW. ALL PIECES OF THE DEVICE WERE RETURNED AND ARE ACCOUNTED FOR. THE NUMBER OF TIMES THE REUSABLE DEVICE HAS BEEN REPROCESSED IS NOT AVAILABLE. THE EXACT ROOT CAUSE OF THIS FAILURE MODE CANNOT BE DETERMINED. CORRECTIVE ACTION WAS TAKEN BY ENDOPLUS IN 2011 TO ADDRESS THIS PARTICULAR FAILURE MODE AND THERE HAVE BEEN NO INCIDENTS OF THIS FAILURE MODE RECURRING ON JAWS PRODUCED POST CORRECTIVE ACTION. THE JAW WHICH BROKE ON THIS 88-8333 WAS CLEARLY MANUFACTURED PRIOR TO THE IMPLEMENTATION OF 2011 CORRECTIVE ACTION.

    Description of Event or Problem · 1

    THE JAWS OF A LAPAROSCOPIC SLIDELOCK GRASPER BROKE OFF AND FELL INTO A FEMALE PATIENT DURING A PROCEDURE. THE PHYSICIAN WAS ABLE TO RETRIEVE THE BROKEN JAW FROM THE PATIENT AND AN X-RAY WAS PERFORMED TO VERIFY THAT NO ADDITIONAL PIECES REMAINED IN THE PATIENT. NO PATIENT INJURY HAS BEEN REPORTED AND ALL PIECES OF THE DEVICE HAVE BEEN ACCOUNTED FOR BY THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452861 SNOWDEN PENCER ATRAMATIC GRASPER SLIDE LOCK HANDLE HET ENDOPLUS, INC. 88-8333 NOT LEGIBLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention