BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG, 5MM PEEK HANDLE, 45CM

    MDR report key: 7001782 · Received November 3, 2017

    Report

    Report Number
    0002936485-2017-01051
    Event Type
    Malfunction
    Date Received
    November 3, 2017
    Date of Event
    October 9, 2017
    Report Date
    November 3, 2017
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    OCZ
    PMA / PMN Number
    K973259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALLEGED FAILURE: EIB PCS- (B)(6) FAILED TEST (B)(4). THE FAILURE ALLEGED IN THE COMPLAINT RECORD WAS NOT CONFIRMED/DUPLICATED DURING THE PRODUCT INVESTIGATION. THE PROBABLE ROOT CAUSE/S COULD BE NORMAL WEAR. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS NOT CONFIRMED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780075 PKG, 5MM PEEK HANDLE, 45CM ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED OCZ STRYKER ENDOSCOPY-SAN JOSE 0342941C

    Patients

    Seq Age Sex Outcome Treatment
    1