BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPSY CUP 5FR SEMI FLEX

    MDR report key: 3946136 · Received July 21, 2014

    Report

    Report Number
    0002936485-2014-00512
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HIH
    PMA / PMN Number
    K040390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING REPAIR DIAGNOSTIC CODES WERE IDENTIFIED: (1) RUST ON HANDLE. THE FOLLOWING SERVICE CODES WERE IDENTIFIED: (1) SWAP LAPAROSCOPIC INSTRUMENT. THIS DOES CONFIRM THE ALLEGED FAILURE MODE OF DETACHED/ BROKEN DEVICE. PROBABLE ROOT CAUSE: 1. USER EXCESSIVE FORCE OR TORQUE; 2. MANUFACTURING/ASSEMBLY ERROR; 3. SEVERE SHIPPING CONDITIONS; 4. USER ERROR IN NOT PROPERLY INSPECTING UNIT PRIOR TO USE; 5. MATERIAL/DESIGN ERROR; 6. CONSTANT IRRIGATION FLOW IS NOT MAINTAINED LEADING TO LIMITED FIELD OF VIEW; 7. LOW LUBRICITY OF INSTRUMENT SHAFT; 8. USE OF INCOMPATIBLE INSTRUMENTATION/HARDWARE; 9. CORROSION OR RUSTING; 10. IMPROPER CLEANING/STERILIZATION. IN SUM, THE UNIT WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE BECAME DETACHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE BECAME DETACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424705 BIOPSY CUP 5FR SEMI FLEX HYSTEROSCOPE (AND ACCESSORIES) HIH STRYKER ENDOSCOPY-SAN JOSE 1342773

    Patients

    Seq Age Sex Outcome Treatment
    1