BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-MAX ACCESSORIES

    MDR report key: 1963048 · Received January 18, 2011

    Report

    Report Number
    1643264-2011-00001
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 12, 2010
    Report Date
    December 17, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY OKLAHOMA CITY MANUFACTURE
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW, INC. ENDOSCOPY DIV IS SUBMITTING THE ENCLOSED REPORT TO COMPLY WITH 21 CFR 803, THE MDR REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY SMITH & NEPHEW INC. ENDOSCOPY DIV WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE OF THE REPORT WAS REQUIRED BY FDA. THE USER FACILITY APPLIED THE TMAX TO A FULLY EXTENDED SECTION OF THE O.R. TABLE CONTRARY TO THE INSTRUCTIONS FOR USE (IFU). THE LOAD INTRODUCED BY THE INCORRECT MOUNTING LOCATION CAUSED THE O.R. TABLE TOP TO FAIL IN A MANNER THAT DROPPED THE PATIENT. IN ADDITION TO THE INCORRECT MOUNTING, THE O.R. TABLE IN QUESTION WAS NOT ON THE APPROVED TABLE LIST WHICH IS OUTLINED IN THE IFU. (B)(4).

    Description of Event or Problem · 1

    THE T-MAX WAS MOUNTED ON AN OPT 100 SURGICAL TABLE; WHEN THE SHOULDER PROCEDURE FINISHED, WHILE THE CIRCULATING NURSES WERE DOWNLOADING THE PATIENT, THE TABLE DETACHED FROM THE CENTRAL HINGE AND TABLE, T-MAX AND PATIENT FELL DOWN (HEAD DOWN AND FEET UP). PATIENT BANGED HIS HEAD AGAINST THE ANESTHESIA'S MONITOR AND STAYED IN OBSERVATION IN INTENSIVE CARE DEP. FOR ONE DAY (AS PER HOSPITAL PROCEDURE IN THIS CASE) AND THEN WENT HOME APPARENTLY WITH NO CONSEQUENCES. T-MAX DIDN'T BREAK IN ANY PART AND REMAINED HOOKED AT THE TABLE; SO IT SEEMS THAT EVERYTHING WAS GOOD. THE TABLE MANUFACTURER OPT (OFFICINE PROTESI TRENTO, THE MAJOR (B)(4) SURGICAL TABLE PRODUCER, WELL KNOWN ALSO IN EUROPE) WHEN ASKED ABOUT THE REASON OF THE ACCIDENT, POINTED OUT THAT AN UNKNOWN TOOL (MEANS NOT MADE BY OPT) WAS ATTACHED TO THE TABLE AT THE "HEAD" (CEPHALIC) PART CAUSING A WING (A TORQUE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T-MAX ACCESSORIES T-MAX II, SHOULDER EXPOSURE POSITIONER HRX SMITH & NEPHEW ENDOSCOPY OKLAHOMA CITY MANUFACTURE 7210551

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization