BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLAT-PANEL ROLL STAND BASE

    MDR report key: 4974154 · Received August 5, 2015

    Report

    Report Number
    0002936485-2015-00707
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    July 14, 2015
    Report Date
    July 14, 2015
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    BZN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. THE COMPLAINT WILL BE CLOSED WITHOUT A DETAILED INVESTIGATION REPORT AND BASED ON PROBABLE ROOT CAUSE. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED, A FULL EVALUATION WILL BE CONDUCTED, AND THE INVESTIGATION WILL BE UPDATED WITH THE NEW RESULTS. PROBABLE ROOT CAUSE FOR THE REPORTED FAILURE INVOLVING THIS DEVICE COULD HAVE BEEN CAUSED BY: MANUFACTURING NONCONFORMITY ((B)(4)). TOO MUCH EQUIPMENT. LOOSE / BROKEN WHEELS. DAMAGE DURING SHIPPING /HANDLING. USE ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STAND ROLLED OVER THE BACK OF THE SPECIALIST'S HEEL AS SHE WAS PULLING THE STAND, LEAVING A LACERATION THAT REQUIRED 5 STITCHES ON HER UPPER HEEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STAND ROLLED OVER THE BACK OF THE SPECIALIST'S HEEL AS SHE WAS PULLING THE STAND, LEAVING A LACERATION THAT REQUIRED 5 STITCHES ON HER UPPER HEEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516773 FLAT-PANEL ROLL STAND BASE CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT) BZN STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1