BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALLEN MEDICAL SYSTEM

    MDR report key: 1064016 · Received June 19, 2008

    Report

    Report Number
    1221538-2008-00004
    Event Type
    Other
    Date Received
    June 19, 2008
    Report Date
    May 19, 2008
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RETURN, ENGINEERING EVAL OF THE STIRRUPS REVEALED THAT THEY FUNCTIONED PROPERLY WITH JUST ONE EXCEPTION: THE PT RIGHT STIRRUP FLOATING BOOT TENSION WAS TOO LOOSE. THIS IS NOT A SAFETY ISSUE, BECAUSE ONCE THE LEG IS PLACED IN THE BOOT, IT IS NO LONGER CAPABLE OF SPINNING FREELY. BASED ON THIS INVESTIGATION, THE MOST LIKELY ROOT CAUSE FOR THE PATIENT INCIDENT IS INSTALLATION/USER ERROR. THE FAILURE DESCRIBED BY THE USERS COULD NOT BE REPLICATED HERE.

    Description of Event or Problem · 1

    IN 2008, AN ALLEN SALES REP FORWARDED A CUSTOMER'S REQUEST FOR A STIRRUP TRADE-IN FOLLOWING A REPORTED PT INCIDENT WHICH MAY HAVE RESULTED IN INJURY. THE HEAD NURSE FROM MEDICAL CENTER, TOLD AN ALLEN REP THAT A PT'S LEG HAD COME FREE FROM THE STIRRUP, WHICH HAVE BEEN IN USE FOR APPROX 10 YEARS, DURING A PROCEDURE. THE ALLEN SALES REP LEARNED THAT THE UNIDENTIFIED PT IS UNDERGOING A REGIMENT OF PHYSICAL THERAPY. IT WAS UNCLEAR IF THE PATIENT'S PT WAS RESULTING FROM THE INCIDENT OR FROM THE PT PRE-CONDITION AND SUBSEQUENT MEDICAL PROCEDURE THAT TOOK PLACE. INQUIRIES TO THE FACILITY ABOUT THE CASE AND THE PT CONDITION HAVE NOT BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEN MEDICAL SYSTEM POWER ASSIST LITHOTOMY STIRRUPS FWZ ALLEN MEDICAL SYSTEMS A-10023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention