BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM, 33CM PEEK MONOPOLAR HANDLE 33CM

    MDR report key: 6200354 · Received December 22, 2016

    Report

    Report Number
    0002936485-2016-01215
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    November 29, 2016
    Report Date
    May 9, 2017
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    OCZ
    PMA / PMN Number
    K973259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURE DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS. (B)(4).

    Additional Manufacturer Narrative · 1

    ALLEGED FAILURE: FAILED INSULATION . THE FAILURE(S) IDENTIFIED IN THE INVESTIGATION IS CONSISTENT WITH THE COMPLAINT RECORD. THE PROBABLE ROOT CAUSE/S COULD BE NORMAL WEAR, USER MISUSE, AND IMPROPER STERILIZATION METHODS. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. THE DEVICE MANUFACTURER DATE IS NOT KNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULATION WAS DAMAGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULATION WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849787 5MM, 33CM PEEK MONOPOLAR HANDLE 33CM ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED OCZ STRYKER ENDOSCOPY-SAN JOSE 1142232D¿

    Patients

    Seq Age Sex Outcome Treatment
    1