BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH ENDOSCOPIC MULTIPLE CLIP APPLIER

    MDR report key: 41416 · Received October 4, 1996

    Report

    Report Number
    1628808-1996-00060
    Event Type
    Injury
    Date Received
    October 4, 1996
    Date of Event
    September 5, 1996
    Report Date
    October 4, 1996
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A4;B,6,7;D10: INFO INAVAILABLE: 9/9/96 1400 MESSAGE AND 800# LEFT ON ANSWERING MACHINE FOR RISH MGMT. BAH 9/9/96 1505 AND SAID SHE WAS AWARE OF EVENT AND WOULD SUBMIT A MEDWATCH TO EES AND FDA. TKB 10/17/96 PT ID # 173282, DOB 4/29/57, FEMALE, KJB

    Description of Event or Problem · 1

    MEDWATCH # 1001 WAS RECEIVED ON 10/17/96 STATING "LAPROSCOPIC CHOLECYSTECTOMY CLIP APPLIED TO ARTERY. CLIP CAME OFF ARTERY. CASE WAS CONVERTED TO AN OPEN PROCEDURE AND THE ARTERY LIGATED. THIS EXTENDED RECOVERY TIME AND HOSPITILIZATION OF PT." 9/9/96 DR. E. PERFORMING A LAPAROSCOPIC CHOLECYSTECTOMY. HE WAS USING AN ER320. AFTER PLACING 3 CLIPS ALONG CYSTIC ARTERY, VESSEL WAS DIVIDED. AT THIS POINT IN TIME, ALL APPEARED TO BE NORMAL. CYSTIC DUCT WAS HANDLED IN A SIMILAR FASHION. WHILE REMOVING GALLBLADDER FROM BED, A SIGNIFICANT AMOUNT OF BLEEDING WAS ENCOUNTERED WHICH REQUIRED CONVERSION TO AN OPEN PROCEDURE. AT THIS TIME IT WAS NOTED CLIPS WERE NO LONGER ON CYSTIC ARTERY AND RECOVERY OF CLIPS SHOWED THAT THEY WERE NOT SECURE. THESE CLIPS WERE DISPOSED AS WAS INSTRUMENT. 9/9/96, THERE WAS NO VIDIO THEREFORE, WE HAVE NO MATERIAL TO EXAMINE,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC MULTIPLE CLIP APPLIER ENDOSCOPIC MULTIPLE CLIP APPLIER GDO ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention