BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATS 1200 TOURNIQUET SYSTEM

    MDR report key: 2111221 · Received May 11, 2011

    Report

    Report Number
    1526350-2011-00093
    Event Type
    Injury
    Date Received
    May 11, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 11, 2011
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    KCY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION OR REPAIR. THE SERVICE RECORDS INDICATE THAT THE DEVICE HAS NOT BEEN IN FOR SERVICE SINCE PURCHASED IN 2004. CLINICAL FOLLOW UP INDICATED ZIMMER SINGLE USE STERILE CUFFS ARE BEING RE-USED AFTER GAS STERILIZATION, AND THE RECOMMENDED '2 FINGER' PROTOCOL FOR FITTING CUFF IS NOT BEING FOLLOWED. UNABLE TO DETERMINE EXACT CAUSE OF REPORTED COMPLAINT AS DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER ATS 1200 WAS INVOLVED IN AN INCIDENT THAT CAUSED PT HARM. ADDITIONAL CLINICAL FOLLOW UP WITH THE HOSPITAL ON (B)(6) 2011, INDICATED THAT THE STAFF REPORTED THAT THE PT HAD THIN ARMS AND WAS USING A REPROCESSED ZIMMER SINGLE STERILE CUFF. THE TOURNIQUET WAS APPLIED BY THE SURGEON WITH WEBRIL UNDERNEATH, USUAL PROTOCOL IS TO APPLY TIGHTLY, WITHOUT ROOM FOR 2 FINGERS. UPON REMOVAL OF THE CUFF AFTER A 98" PROCEDURE, "SKIN WAS FOUND TO BE ECCHYMOTIC UNDER CUFF." MARCAINE INJECTION WAS REQUIRED TO ALLEVIATE PAIN DURING POST-OP PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATS 1200 TOURNIQUET SYSTEM ATS 1200 TOURNIQUET SYSTEM KCY ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1