BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FILSHIE CLIP

    MDR report key: 2226947 · Received August 24, 2011

    Report

    Report Number
    8021955-2011-00005
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    June 28, 2011
    Report Date
    August 18, 2011
    Manufacturer
    FEMCARE-NIKOMED LTD
    Product Code
    KNH
    PMA / PMN Number
    P920046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FILSHIE CLIP HAS BEEN RETURNED TO US DISTRIBUTOR (COOPER SURGICAL INC) WHO HAS CONDUCTED INITIAL EVALUATION DESCRIBED BELOW: ONE FILSHIE CLIP WAS RETURNED TO COOPER SURGICAL FULLY ACTUATED. THE RETURNED CLIP EXHIBITED NO NONCONFORMITY. VISUAL EVIDENCE SUGGESTS THE CLIP WAS IMPROPERLY PLACED ON THE FALLOPIAN TUBE. A REVIEW OF THE FEMCARE-NIKOMED COMPLAINT DATABASE REVEALS NO OTHER COMPLAINTS AGAINST (B)(4) LOT # 28666. THIS EVENT ALSO REPORTED BY FEMCARE-NIKOMED US DISTRIBUTOR COOPER SURGICAL INC - REPORT # (B)(4).

    Description of Event or Problem · 1

    SURGEON WAS PERFORMING A LAPAROSCOPIC PROCEDURE (FALLOPIAN TUBE LIGATION). THE FILSHIE CLIP WAS APPLIED TO THE LEFT FALLOPIAN TUBE BY THE SURGEON. BOTH THE SURGEON AND THE SCRUB TECH VISUALISED THE CLIP WAS ON THE TUBE. UPON REMOVING THE APPLIER, THE CLIP FELL OFF THE TUBE LEAVING A SLIGHTLY BLOODY MARK WHERE THE CLIP WAS ON THE TUBE. THE SLIP WAS THEN REMOVED FROM THE PT AND A NEW CLIP WAS APPLIED IN ITS PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FILSHIE CLIP CONTRACEPTIVE TUBAL OCCLUSION DEVICE KNH FEMCARE-NIKOMED LTD FE-20U-904 28666

    Patients

    Seq Age Sex Outcome Treatment
    1 Other