BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER

    MDR report key: 78300 · Received March 20, 1997

    Report

    Report Number
    1527736-1997-00295
    Event Type
    Injury
    Date Received
    March 20, 1997
    Date of Event
    February 13, 1997
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    GDO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE INSTRUMENT WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE CASE PROCEEDED UNEVENTFULLY BUT WITHIN 12 HOURS POST-OP, PT SHOWED SIGNS OF BLEEDING. PT WAS RE-OPERATED AND SURGEON FUND A CLIP HAD SLIPPED OFF THE CYSTIC ARTERY. THE ORIGINAL INSTRUMENT (ER320) WAS FROM A KIT. CLINICAL FOLLOW-UP: 2/17/97 1519 MESSAGE AND 800# LEFT FOR THE RISK MGR TO CALL BACK. 2/27/97 DR. HAD PERFORMED A LAPAROSCOPIC CHOLECYSTECTOMY. DURING THE OPERATIVE PROCEDURE, ALL APPEARED TO BE WELL. HOWEVER, LATER THE PT REQUIRED REEXPLORATION AND THERE WAS FOUND TO BE NO CLIPS ON THE CYSTIC ARTERY. THE CLIPS WERE RECOVERED, BUT WERE NOT SAVED. THERE IS NOT OTHER MATERIAL FOR CO TO EXAMINE .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER ENDOSCOPIC CLIP APPLIER GDO ETHICON ENDO-SURGERY NA UN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention