BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG, 5MM PEEK MONOPOLAR HANDLE

    MDR report key: 6143409 · Received December 2, 2016

    Report

    Report Number
    0002936485-2016-01138
    Event Type
    Malfunction
    Date Received
    December 2, 2016
    Date of Event
    November 8, 2016
    Report Date
    May 8, 2017
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    OCZ
    PMA / PMN Number
    K973259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALLEGED FAILURE: INSTRUMEDICS EIB JAYLEN HARRIS AFT INSULATION CRACKED, COMPROMISED, BROKE, OR BREACHED (FAILED INSULSCAN). THE FAILURE ALLEGED FOR "COMPROMISED INSULATION" IN THE COMPLAINT RECORD WAS CONFIRMED/DUPLICATED DURING THE PRODUCT INVESTIGATION DUE TO SCRATCHED INSULATION. THE PROBABLE ROOT CAUSE/S COULD BE USER MISUSE. 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).

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULATION HAD BEEN COMPROMISED.

    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
    794207 PKG, 5MM PEEK MONOPOLAR HANDLE ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED OCZ STRYKER ENDOSCOPY-SAN JOSE 1641220K

    Patients

    Seq Age Sex Outcome Treatment
    1