BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG, 5MM PEEK MONOPOLAR HANDLE

    MDR report key: 6104484 · Received November 15, 2016

    Report

    Report Number
    0002936485-2016-01071
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    October 20, 2016
    Report Date
    April 6, 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

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

    Additional Manufacturer Narrative · 1

    ALLEGED FAILURE: FAILED INSULATION TEST . 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 FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. THE DEVICE MANUFACTURE DATE IS NOT KNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULATION HAD BEEN COMPROMISED. THERE WAS NO PATIENT INVOLVMENT AND THEREFORE NO ADVERSE CONSEQUENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULATION HAD BEEN COMPROMISED. THERE WAS NO PATIENT INVOLVEMENT AND THEREFORE NO ADVERSE CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753181 PKG, 5MM PEEK MONOPOLAR HANDLE ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED OCZ STRYKER ENDOSCOPY-SAN JOSE 1341870¿¿H

    Patients

    Seq Age Sex Outcome Treatment
    1