BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURVED MULTI-CUT SCISSORS (4BX)

    MDR report key: 3041632 · Received April 8, 2013

    Report

    Report Number
    0002936485-2013-00132
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GEI
    PMA / PMN Number
    K935237
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SHRUNKEN SHEATH FAILURE MODE WAS CONFIRMED ON THE DEVICE RETURNED FOR EVALUATION. UPON VISUAL INSPECTION IT WAS OBSERVED THAT THE UNIT HAD THE SHEATH RECESSED AT THE TIP. THE UNITS SHOWED SIGNS OF EXTENSIVE USE SUCH AS MANY MULTIPLE SCRATCHES ON THE SHEATH AND FADED LOGO AND MARKINGS. THIS IS INDICATIVE OF REPEATED USE AND STERILIZATION. THERE WERE NO OTHER OBSERVED ANOMALIES. FUNCTIONALITY WAS TESTED AND THE UNIT OPERATED SATISFACTORILY. DIMENSIONAL INSPECTION DEMONSTRATED THE SHEATHS TO HAVE RECESSED FROM 1/16 TO 2/16 OF AN INCH. THERE WERE NO DISCREPANCIES OBSERVED THAT COULD CONTRIBUTE TO THE REPORTED CONDITION. ALL MANUFACTURING PROCESSES WERE COMPLETED ACCORDING TO APPLICABLE PROCEDURES. THE ROOT CAUSE WAS DETERMINED TO BE NORMAL WEAR BECAUSE OF USE. IN SUM, THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULATION SHEATH ON THE DEVICE WAS TOO SHORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULATION SHEATH ON THE DEVICE WAS TOO SHORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143636 CURVED MULTI-CUT SCISSORS (4BX) ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER ENDOSCOPY-SAN JOSE 12099862

    Patients

    Seq Age Sex Outcome Treatment
    1