BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEN

    MDR report key: 6689162 · Received July 6, 2017

    Report

    Report Number
    6689162
    Event Type
    Malfunction
    Date Received
    July 6, 2017
    Date of Event
    May 17, 2017
    Report Date
    June 21, 2017
    Manufacturer
    ALLEN MEDICAL SYSTEMS, INC.
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    STIRRUP TO SUPPORT LEFT LEG OF PATIENT BECAME UNATTACHED TO RAIL OF BED DURING PROCEDURE. LEFT LEG IMMEDIATELY WAS SUPPORTED WITH STERILE STAFF UNTIL BRACKET AND STIRRUP COULD BE REATTACHED TO BED. X-RAY OF LEFT HIP WAS OBTAINED INTRA-OPERATIVELY PRIOR TO PATIENT GOING TO PACU. THE STIRRUP THAT HELD THE PATIENT'S LEG WAS NOT PROPERLY SECURED TO THE BED. THE CLAMP THAT HOLDS THE STIRRUP WAS CLOSED AND THE STIRRUP WAS SITTING ON THE SCREW OF THE CLAMP AS OPPOSED TO BEING PROPERLY SEATED IN THE CLAMP AND SECURED. THE NURSE CHECK TO MAKE SURE THAT THE STIRRUP WAS LOCKED IN BY ATTEMPTING TO TURN THE CLAMP. SHE THOUGHT IT WAS PROPERLY SECURED AS SHE COULDN'T TURN THE CLAMP ANYMORE. COMPLICATIONS: LEFT LOWER STIRRUP CAME OFF OF THE BED DURING THE OPERATION. PATIENT WAS IMMEDIATELY POSITIONED AND THE BED STIRRUP ATTACHMENT WAS CHANGED. NO OBVIOUS INJURY TO THE LEFT LOWER EXTREMITY AND IN AN ABUNDANCE OF PRECAUTION, X-RAYS WERE ORDERED AND TAKEN PRIOR TO PATIENT LEAVING THE OPERATING ROOM, WHICH DID APPEAR GROSSLY NEGATIVE. LEFT HIP 2 VIEWS. INDICATION: EVALUATE FOR FRACTURE DISLOCATION LEFT HIP. LEFT LEG CAME OF CYSTOSCOPY SETUP STIRRUP. FINDINGS: MILD DEGENERATIVE CHANGES LEFT HIP. NO FRACTURE OR DISLOCATION NOTED. A SURGICAL DRAIN IN THE PELVIS AND RECTOSIGMOID ANASTOMOTIC SUTURES SEEN. THERE IS A SKIN FOLD OVERLYING THE INFERIOR PUBIC RAMUS THAT I DO NOT BELIEVE REPRESENTS A FRACTURE. IMPRESSION: NO FRACTURE OR DISLOCATION LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471271 ALLEN OPERATING ROOM ACCESSORIES TABLE TRAY FWZ ALLEN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR NOT KNOWN.| UNKNOWN.