BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 3924348 · Received July 9, 2014

    Report

    Report Number
    0002090040-2014-00026
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 12, 2014
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS PHOENIX
    Product Code
    NMJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) FOR AN EVALUATION. THE RETURNED COMPLAINT DEVICE WAS RECEIVED OPEN WITH THE ORIGINAL STRYKER SUSTAINABILITY SOLUTIONS PACKAGING WITH EVIDENCE OF USE (BIO-BURDEN PRESENT). NO VISIBLE DAMAGE WAS DETECTED DURING VISUAL INSPECTION. THE DEVICE WAS RECEIVED WITH 16 TITANIUM LIGATING CLIPS. THE DEVICE WAS ACTUATED TO CONFIRM THAT THE DEVICE WORKED AS INTENDED FOR USE. A REVIEW OF THE DHR SUPPORTS THAT THE DEVICE IS UNLIKELY TO HAVE BEEN RELEASED FROM STRYKER WITH THE REPORTED FAILURE MODE. THEREFORE, THE MOST LIKELY ROOT CAUSES ARE: ¿ MISHANDLING SUBSEQUENT TO DISTRIBUTION FROM STRYKER. ¿ OM DEFECT. THIS REPORT IS BEING FILED AS AN INJURY DUE TO SSS BEING IN A 2 YEAR REPORTING CYCLE DUE TO MDR 2090040-2012-00024 FILED WHERE CLIP CUT THOUGH PATIENT'S VESSEL. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, "THE CLIP APPLIER TORE THE VESSEL." THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SIGNIFICANT PROCEDURE DELAY. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401456 NA CLIP, IMPLANTABLE, REPROCESSED NMJ STRYKER SUSTAINABILITY SOLUTIONS PHOENIX UNUSED 601552U

    Patients

    Seq Age Sex Outcome Treatment
    1 Other