BEUDAMED
    FDA Adverse Event Summary report: N

    FILSHIE TUBAL LIGATION SYSTEM CLIPS

    MDR report key: 2834148 · Received October 29, 2012

    Report

    Report Number
    8021955-2012-00001
    Date Received
    October 29, 2012
    Date of Event
    August 9, 2012
    Report Date
    September 13, 2012
    Manufacturer
    COOPER SURGICAL
    Product Code
    KNH
    PMA / PMN Number
    P920046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR OF THE DEVICE IS FEMCARE (B)(4), NOT (B)(4) (AS LISTED BY THE INITIAL REPORTER). FEMCARE-(B)(4) IS FILING THIS REPORT BECAUSE A HEALTH CARE PROFESSIONAL HAS INDICATED AN ADVERSE EVENT. FILSHIE CLIPS COMMONLY CAUSE TISSUE NECROSIS AND SOMETIMES MIGRATE AWAY. AS THERE IS NO EVIDENCE OF A COMPLICATION RELATED TO THE CLIP, FEMCARE-(B)(4) DISAGREES THAT THIS WAS AN ADVERSE EVENT.

    Description of Event or Problem · 1

    PT HAD SAME DAY SURGERY ON (B)(6) 2012 FOR "OPERATIVE LAPAROSCOPY WITH PROXIMAL SALPINGECTOMY, LYSIS OF ADHESIONS, REMOVAL OF BILATERAL FILSHIE CLIPS AND COAGULATION OF SUSPECTED ENDOMETRIOSIS. THE PT PRESENTED WITH PELVIC PAIN AND IT WAS REPORTED TO BE GOING ON FOR ABOUT A YR. THE SURGERY REVEALED OVARIES NORMAL LIMITS, UTERUS AND ANTERIOR FUNDAL FIBROID. SOME DILATION OF PROXIMAL LEFT FALLOPIAN TUBE. FILSHIE CLIP WAS COMPLETELY DISCONNECTED FROM THE TUBE AND ADHERED IN THE MESOSALPINX AND TO THE CORNUL REGION OF THE UTERUS. TUBES SEPARATED BILATERALLY AND FILSHIE CLIP WAS NOT ATTACHED TO THE RIGHT FALLOPIAN TUBE AS WELL WHICH WAS JUST SITTING IN THE MESOSALPINX. THE FILSHIE CLIP ON LEFT WAS GRASPED DURING THE PROCEDURE. ADHESIONS WERE LYSED SHARPLY AFTER ELEVATION WITH LAP SCISSORS. THE DEVICE DELIVERED THROUGH THE UMBILICAL PORT. FILSHIE CLIP WAS HANGING IN THE MESOSALPINX ON THE RIGHT HAND SITE. GRASPED AGAIN AND EXCISED WITH DELIVERY ALSO THROUGH UMBILICAL PORT. HEMOSTASIS NOTED AND PT RECOVERED AND DISCHARGED HOME. NO MORE INFO AVAILABLE ON AGE OF FILSHIE CLIPS. UNABLE TO DETERMINE WHEN DEVICE PLACED. NOT DONE AT THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FILSHIE TUBAL LIGATION SYSTEM CLIPS FILSHIE CLIPS KNH COOPER SURGICAL UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| R