BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER

    MDR report key: 97385 · Received June 11, 1997

    Report

    Report Number
    1527736-1997-01209
    Event Type
    Injury
    Date Received
    June 11, 1997
    Date of Event
    March 11, 1997
    Report Date
    June 9, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A LETTER FROM THE SURGEON, FOUR DAYS AFTER A LAPAROSCOPIC CHOLECYSTECTOMY THE PT DEVELOPED A BILE LEAK DUE TO A NECROSED CYSTIC DUCT. THIS WAS INITIALLY TREATED WITH ERCP AND STENTING, BUT THE STENT BECAME DISLODGED AN ULTIMATELY AN OPEN EXPLORATION WAS DONE AND THE DEFECT WAS REPAIRED OVER A T-TUBE. THE REP WAS NOTIFIED TO COLLECT FURTHER INFO. 5/19/1995 1550 THE REP REPORTED THE PRODUCT WAS AN ER320, HE HAS NO OTHER ADDITIONAL INFO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention