BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG, 5MM PEEK MONOPOLAR HANDLE

    MDR report key: 6063272 · Received October 28, 2016

    Report

    Report Number
    0002936485-2016-01016
    Event Type
    Malfunction
    Date Received
    October 28, 2016
    Date of Event
    September 30, 2016
    Report Date
    March 20, 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

    LOT NUMBER IS UNKNOWN; THEREFORE, MANUFACTURE DATE CAN NOT BE CONFIRMED. ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    ALLEGED FAILURE: INSTRUMEDICS. EIB JH. LOT 09302016. PO 151861 SERVICE CONTRACT NO CHARGE. SHAFT INSULATION CRACKED, COMPROMISED, BROKE OR BREACHED (FAILED INSULSCAN) THE FAILURE(S) IDENTIFIED IN THE INVESTIGATION IS CONSISTENT WITH THE COMPLAINT RECORD. THE PROBABLE ROOT CAUSE COULD BE USER MISUSE. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. (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
    714805 PKG, 5MM PEEK MONOPOLAR HANDLE ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED OCZ STRYKER ENDOSCOPY-SAN JOSE 1641586K

    Patients

    Seq Age Sex Outcome Treatment
    1