BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10 MM ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3020798 · Received March 20, 2013

    Report

    Report Number
    MW5029460
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 20, 2013
    Manufacturer
    ETHICON
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WITH SYMPTOMATIC CHOLELITHIASIS, UNDERWENT AN ELECTIVE LAP CHOLE ON (B)(6) 2013. THE SURGEON REPORTED THAT THE CLIP FAILED AT THE CROTCH OF THE DUCT DURING SURGERY. ENDO LOOPS WERE USED TO FINISH THE PROCEDURE. WE THEN ISOLATED THE CYSTIC DUCT. WE ALSO ISOLATED THE CYSTIC ARTERY, AND WE HAD A PRETTY GOOD CRITICAL VIEW, SO WE PLACED 1 DISTAL CLIP TO THE DISTAL CYSTIC DUCT AND 2 CLIPS ON THE PROXIMAL CYSTIC DUCT, AND ALSO 1 CLIP TO THE DISTAL CYSTIC ARTERY AND 2 CLIPS ON THE PROXIMAL CYSTIC ARTERY. THERE WAS A BULGE ON THE CLIPS OF THE CYSTIC DUCT, BOTH DISTAL AND PROXIMAL PORTIONS, AND SO WE PLACED THE ENDOLOOP JUST PROXIMAL TO THE CLIP, AND WE CONFIRMED THAT THERE WAS NO BILE LEAK FROM THE PROXIMAL CYSTIC DUCT. A PICTURE WAS TAKEN AND THE GUN WAS SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115573 10 MM ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER LIGA CLIP 10 ML DISPOSABLE W/20 MED/LG TITANIUM CLIPS FZP ETHICON REF ER320 K4C293

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization