BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTURION CIRCLAMP

    MDR report key: 1011290 · Received March 11, 2008

    Report

    Report Number
    1824619-2008-00001
    Event Type
    Injury
    Date Received
    March 11, 2008
    Date of Event
    January 1, 2008
    Report Date
    January 25, 2008
    Manufacturer
    TRI-STATE HOSPITAL SUPPLY CORP.
    Product Code
    HFX
    PMA / PMN Number
    K890897
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE BELL CAME OFF DURING A PROCEDURE. AS THIS IS TRI-STATE'S LATEST RELEASED CIRCLAMP, THE NATURE OF THE COMPLAINT WAS DISCUSSED WITH THE SALES REP ON 1/28. THE DETAIL OF THE REPORTED NONCONFORMANCE DESCRIBES THE BELL COMING OUT OF THE SOCKET DURING THE PROCEDURE. BASED ON THE DESIGN OF THE CIRCLAMP, THE LIKELY CAUSE FOR THIS CONDITION WOULD BE THAT THE PHYSICIAN DID NOT TIGHTEN THE THUMBNUT TO PROVIDE ADEQUATE FORCE. IT SHOULD BE NOTED, THE HOSPITAL REMAINS CONFIDENT ENOUGH IN THE PRODUCT TO CONTINUE USING KITS FROM THIS LOT AND NO FURTHER INCIDENTS HAVE BEEN REPORTED. THE CLAMP IN QUESTION WAS RETURNED TO HOWELL FACILITY (CSC#01) FOR ANALYSIS, ON 02/11/2008. THE INITIAL CHECK WAS FOR PROPER ASSEMBLY. IT WAS OBSERVED THAT THERE WAS ACCEPTABLE SPACING BETWEEN THE BASE AND ARM. THE BELL (BELL110) WHEN ASSEMBLED WAS ALIGNED, WITH ZERO DEGREES FROM VERTICAL (NOMINALLY PERFECT). THE DESIGNED SPHERICAL RADIUS IS 0.375" AND IT WAS MEASURED AT 0.378" (WITHIN TOLERANCE). THE HEIGHT MEASURED AT 1.427" WHICH IS 0.001" UNDER NOMINAL (WITHIN TOLERANCE). THE SLIPPING CONDITION COULD NOT BE REPRODUCED IN A FINGER TIGHT, OR TWO TURN LOOSENED CONDITION. THE CLAMP MEETS ALL SPECIFICATIONS AND IS WITHIN TOLERANCE. WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THIS COMPLAINT AT THIS TIME. NO CORRECTIVE MEASURES WILL BE TAKEN AT THIS TIME. AS A PREVENTIVE MEASURE, THE SALES REP WILL FORWARD THE LITERATURE AND ASSEMBLY INSTRUCTIONS FOR THE CIRCLAMP TO THE CUSTOMER. NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    DOCTOR DOING PROCEDURE HAD THE BELL POP OFF THE TOP WHILE CUTTING CAUSING BLEEDING AND SUTURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTURION CIRCLAMP HFX, CLAMP, CIRCUMCISION HFX TRI-STATE HOSPITAL SUPPLY CORP. CIT2680A 10297

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA Required Intervention