BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 1053290 · Received May 16, 2008

    Report

    Report Number
    1518293-2008-00051
    Event Type
    Other
    Date Received
    May 16, 2008
    Date of Event
    May 16, 2003
    Report Date
    June 2, 2003
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS A SIDE BOARD INCLUDED WITH EACH TABLE FOR USE IN THIS TYPE OF INSTANCE, BUT WAS NOT IN USE. PERHAPS DUE TO SOME LOSS OF LATERAL TABLE MOVEMENT (OR THE USER UNAWARE OF ITS AVAILABILITY). ACCORDING TO CUSTOMER, DISTRIBUTOR'S PEOPLE INSTRUCT USERS OF THE TABLE ON ALL PINCH POINT ISSUES AS A SAFETY ISSUE WHEN THE INSTALLATION IS COMPLETE. CORRECTIVE ACTION: A PAIR OF WRISTLETS (PN235081) WILL BE SENT TO THE CUSTOMER FREE OF CHARGE TO BE USED IN SIMILAR SITUATIONS AS ARM RESTRAINTS. THIS STANDARD ACCESSORY IS EQUIPPED WITH VELCRO WRIST STRAPS TO RESTRAIN PT ARM MOVEMENTS, WITHOUT LOSING ANY LATERAL MOVEMENT. NO EQUIPMENT MALFUNCTION. ISSUE OF APPLICATION TRAINING OF STAFF FOR PT SAFETY POINTS AND ACCESSORIES TO BE USED DURING PROCEDURE.

    Description of Event or Problem · 1

    DATE: ON JUNE 2, 2003 CUSTOMER REPORTS THAT IN 2003 PROCEDURE: CYSTOSCOPY UNDER GENERAL ANESTHESIA EVENT: MALE PT WAS IN LITHOTOMY POSITION FOR A CYSTOSCOPY. PT WAS GIVEN GENERAL ANESTHESIA AND WAS ASLEEP FOR THE PROCEDURE. PT'S LEGS WERE POSITION IN LITHOTOMY POSITION USING INFINITY STIRRUPS. STIRRUPS SECURED TO OUR TABLE WITH OUR UNIVERSAL CLAMPS. UNIVERSAL CLAMPS POSITIONED 1-2 INCHES FROM PERINEAL END OF TABLESIDE RAIL. THE PT'S ARM EXTENDED AWAY FROM THE PT'S BODY AND WAS EXTENDED OFF THE TABLE TOWARD THE TOWER. THERE WAS NO ROOM BETWEEN THE UNIVERSAL CLAMP AND PT'S THIGH TO SECURE THE ARM TO THE SIDE OF THE PT. TABLE WAS MOVED TOWARD THE TOWER TO FACILITATE PROCEDURE. HAND BECAME TRAPPED BETWEEN THE TOWER AND UNIVERSAL CLAMP. PT COULD OFFER NO COMPLAINT OF PRESSURE OR PAIN AS PT WAS ASLEEP. UPON EXAMINATION OF PT'S HAND AFTER THE PROCEDURE, THERE WERE RED PRESSURE MARKS ON THE PT'S FINGERS. ALL BUT ONE FINGER REGAINED ITS NORMAL COLOR BY TIME PT WAS REMOVED FROM THE UROLOGY TABLE. ONE REMAINED RED UPON TRANSPORT TO RECOVERY. THE PT IS DOING WELL AND RPTR IS NOT AWARE OF ANY PERMANENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUT EXT DR FINAL ASSY-STANDARD UROLOGY SUITE KQS LIEBEL-FLARSHEIM CO. HUT EXT DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other