BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDER 2 TENET 7615

    MDR report key: 6095804 · Received November 11, 2016

    Report

    Report Number
    1643264-2016-00223
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Report Date
    May 4, 2017
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GDC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED BY MANUFACTURER. THERE WAS NO RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. THE UNIT PASSED ALL FUNCTIONAL TESTS INCLUDING LOAD/PULL TESTS. THE COMPLAINT WAS NOT VERIFIED AND THE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE REPORTED MALFUNCTION COULD NOT BE DUPLICATED DURING THE FUNCTIONAL TESTING PROCESS. MANUFACTURING RECORDS SHOW THAT THE DEVICE WAS RELEASED INTO DISTRIBUTION NEW IN DECEMBER OF 2014. THERE ARE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION OR WOULD NOT BE ABLE TO PERFORM AS INTENDED. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE JOINTS OF THE SPIDER 2 TENET 7615 ASSEMBLY MOVE FREELY. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748521 SPIDER 2 TENET 7615 TABLE, OPERATING-ROOM, ELECTRICAL GDC SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1