BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON ENDO-SURGERY LLC

    MDR report key: 2885739 · Received November 9, 2012

    Report

    Report Number
    2885739
    Event Type
    Malfunction
    Date Received
    November 9, 2012
    Date of Event
    October 26, 2012
    Report Date
    November 7, 2012
    Manufacturer
    ETHICON ENDO SURGERY
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS IS A (B)(6) MALE WHO UNDERWENT A SCHEDULED LAPAROSCOPIC CHOLECYSTECTOMY WITH CHOLANGIOGRAM ON (B)(6) 2012. DURING THE PROCEDURE, THE GALLBLADDER WAS PLACED WITHIN AN ENDOCATCH, WHICH MISFIRED UPON REMOVAL FROM THE ABDOMEN. THE GALLBLADDER COULD NOT BE LOCATED. FURTHER EVAL TO LOCATE THE GALLBLADDER INCLUDED LAPAROSCOPIC AND FLUOROSCOPIC WHICH SHOWN NO EVIDENCE OF A GALLBLADDER IN THE ABDOMEN. THE TEAM SEARCHED THE SURGICAL FIELD FOR THE GALLBLADDER AND WAS UNSUCCESSFUL. THE PT CONDITION REMAINED STABLE AND WAS DISCHARGED HOME ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO-SURGERY LLC ENDOSCOPIC POUCH GCJ ETHICON ENDO SURGERY H208POUCH26 J4CC4X
    2 ETHICON ENDO-SURGERY LLC ENDOSCOPIC POUCH GCJ ETHICON ENDO SURGERY H208POUCH26 J4C889

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other