BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CROSSFLOW INTEGRATED ARTHROSCOPY PUMP - INTERNATIONAL KIT

    MDR report key: 7786967 · Received August 15, 2018

    Report

    Report Number
    0002936485-2018-00578
    Event Type
    Injury
    Date Received
    August 15, 2018
    Date of Event
    July 20, 2018
    Report Date
    April 26, 2019
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HRX
    UDI-DI
    07613327058048
    PMA / PMN Number
    K123441
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED RATIONALE FROM SERIOUS INJURY TO NO REPORT REQUIRED. THE REPORTED FAILURE CANNOT BE CONFIRMED. THE DEVICE WAS NOT RECEIVED FOR INVESTIGATION AT STRYKER ENDOSCOPY BECAUSE IT WAS REPAIRED LOCALLY IN STRYKER GERMANY; THEREFORE THE REPORTED FAILURE CANNOT BE CONFIRMED. THE COMPLAINT WILL BE CLOSED WITHOUT A DETAILED INVESTIGATION REPORT AND BASED ON PROBABLE ROOT CAUSE. IN THE EVENT THAT THE DEVICE IS RECEIVED AT STRYKER ENDOSCOPY, THE COMPLAINT WILL BE REOPENED, A FULL EVALUATION WILL BE CONDUCTED, AND THE INVESTIGATION WILL BE UPDATED WITH THE NEW RESULTS. THE TECHNICAL SERVICE REPORT IS ATTACHED (SEE COMMUNICATION LOG), AND INDICATES: "EXTERNAL REPAIR - GERMANY - PASSED FOR SHIPPING 9/8/2018 REPAIR DETAILS: FAULT: FAULTY STEPPER MOTOR - UNABLE TO REMOVE CASSETTE" THE REPORTED EVENT INVOLVING THIS FAILURE AND DEVICE COULD HAVE BEEN CAUSED BY: TOLERANCE STACK UP ISSUE (CASSETTE/ TUBING DESIGN), MANUFACTURING/ASSEMBLY ERROR, USE ERROR. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 0

    PER ADDITIONAL INFORMATION RECEIVED, A REPLACEMENT DEVICE WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY WITH NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES, THEREFORE MAKING THIS EVENT NOT REPORTABLE.

    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 SURGERY WAS ABORTED DUE TO THE DEVICE NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627025 CROSSFLOW INTEGRATED ARTHROSCOPY PUMP - INTERNATIONAL KIT ARTHROSCOPE HRX STRYKER ENDOSCOPY-SAN JOSE 07613327058048

    Patients

    Seq Age Sex Outcome Treatment
    1 Other