BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10MM, 33CM PEEK MONOPOLAR HANDLE

    MDR report key: 2951064 · Received February 8, 2013

    Report

    Report Number
    0002936485-2013-00016
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    KOG
    PMA / PMN Number
    K973259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR INVESTIGATION. THE REPORTED FAILURE MODE WAS CONFIRMED. VISUAL INSPECTION CONFIRMED A FRACTURE IN THE INSULATION NEAR THE DISTAL TIP. RUNNING THE HANDLE THROUGH THE INSULATION SCAN TEST CONFIRMED INSULATION FAILURES NEAR THE DISTAL TIP. POSSIBLE ROOT CAUSE(S) FOR THE COMPROMISED INSULATION ARE: (1) MULTIPLE USES OF FLASH STERILIZATION (2) RAPID COOLING AFTER STERILIZATION AND/OR (3) CONTACT WITH METAL TRAY DURING STERILIZATION. AN ACTION HAS BEEN OPENED TO ADDRESS THE INSULATION FAILURE FOR OUR OEM SUPPLIER FOR OUR LAP INSTRUMENTS USING POLYMER RESIN INSULATION. 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 ON THE UNIT HAS BEEN COMPROMISED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULATION ON THE UNIT HAS BEEN COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54033 10MM, 33CM PEEK MONOPOLAR HANDLE ENDOSCOPE AND/OR ACCESSORIES KOG STRYKER ENDOSCOPY-SAN JOSE 0740507D

    Patients

    Seq Age Sex Outcome Treatment
    1