BEUDAMED
    FDA Adverse Event Summary report: N

    3085 SURGICAL TABLE

    MDR report key: 2705591 · Received August 20, 2012

    Report

    Report Number
    1043572-2012-00068
    Date Received
    August 20, 2012
    Date of Event
    July 26, 2012
    Report Date
    August 20, 2012
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    STERIS WAS MADE AWARE OF THIS EVENT ON (B)(4) 2012 AND FILED A MDR (1043572-2012-00068) ON (B)(6) 2012. UPON RECEIPT OF THE USERS MEDWATCH (B)(4) ON (B)(4) 2012 WE CONTACTED THE FACILITY AND CONFIRMED THERE WAS ONLY ONE EVENT; THIS IS THE EVENT REPORTED IN OUR MDR (1043572-2012-00068).

    Additional Manufacturer Narrative · 1

    THE EQUIPMENT OPERATOR MANUAL INSTRUCTIONS INDICATE THAT THE HEAD SECTION IS DESIGNED ONLY FOR THE HEAD OR FEET WITH A LOAD RATING OF 77 LBS (35 KG). A STERIS ACCOUNT MANAGER WENT ON-SITE TO OBTAIN ADDITIONAL INFORMATION; THE USER FACILITY COULD NOT IDENTIFY WHICH TABLE THE EVENT OCCURRED ON. THE ACCOUNT MANAGER CONDUCTED IN-SERVICE TRAINING WHEN ON-SITE REGARDING PROPER USE/OPERATION. THE 3080/3085 SURGICAL TABLES IN USE AT THE FACILITY ARE NOT UNDER STERIS SERVICE CONTRACT AND ARE MAINTAINED BY THE USER FACILITY. THE HEAD SECTION SUBJECT OF THE REPORTED EVENT WAS REMOVED FROM SERVICE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE STEEL HEAD SECTION OF THE SURGICAL TABLE SNAPPED AT THE END OF A PATIENT PROCEDURE, DUE TO PRESSURE OF THE PATIENT'S MID-SECTION AND LOWER BODY. THE TABLE WAS IN REVERSE ORIENTATION; THE HEAD SECTION WAS POSITIONED UNDER THE PATIENT'S PELVIS AND HYDRAULIC STIRRUPS WERE ATTACHED TO THE SIDE RAIL OF THE HEAD SECTION. THE SURGEON STABILIZED THE PATIENT'S LEGS AND NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3085 SURGICAL TABLE SURGICAL TABLE FQO STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1 Other