BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HULKA FALLOPIAN TUBE CLIP

    MDR report key: 1082757 · Received July 23, 2008

    Report

    Report Number
    1418479-2008-00019
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 26, 2008
    Report Date
    July 22, 2008
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS
    Product Code
    HGB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE USER FACILITY RETURNED THE ACTUAL FALLOPIAN TUBE CLIP THAT WAS RETRIEVED FROM THE PT AND ADDITIONALLY, THE REMAINING CLIPS FROM THE SPECIFIC LOT NUMBER. THE PLASTIC JAW COMPONENTS AND THE METAL SPRINGS WERE FOUND TO BE WITHIN DIMENSIONAL AND PHYSICAL TESTS SPECIFICATION. THERE WAS NO DAMAGE TO ANY OF THE COMPONENTS. THE USER FACILITY HAS ONLY TWO APPLICATORS FOR TUBAL PROCEDURES BUT DECLINED TO SEND ANY APPLICATOR IN FOR TEST AND INSPECTION. THE USER FACILITY WAS GIVEN A REPLACEMENT BOX OF CLIPS. CAUSE OF EVENT: NO CONCLUSION CAN BE DRAWN. THE RICHARD WOLF TECHNICAL MANUAL INCLUDES CAUTION WHEN USED FOR PTS WITH ADHESIONS.

    Description of Event or Problem · 1

    DURING A TUBAL PROCEDURE, THE FALLOPIAN TUBE CLIP WAS BEING APPLIED. THE CLIP DID NOT CLOSE PROPERLY. THE METAL SPRING (METALLIC PIECE OF CLIP) CAME OFF IN THE PT. THE SPRING WAS REMOVED WITH AN ATRAUMATIC GRASPER FORCEPS. NO OTHER CLIP WAS APPLIED TO THE FALLOPIAN TUBE. THE METHOD OF TUBAL PROCEDURE WAS CHANGED TO CAUTERIZING WITH KLEPPINGER FORCEPS. THERE WAS APPROX ONE HALF HOUR LONGER WITH THE SURGERY. NO PT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HULKA FALLOPIAN TUBE CLIP HULKA FALLOPIAN TUBE CLIP HGB RICHARD WOLF MEDICAL INSTRUMENTS 4986.09 1388

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR