BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPOUCH SPEC BAG

    MDR report key: 2023743 · Received March 18, 2011

    Report

    Report Number
    3005075853-2011-01082
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 20, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K011501
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED WITH THE SUTURE TORN AND CUT. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE INCIDENT REPORTED. HOWEVER, IT SHOULD BE NOTED THAT AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THE POTENTIAL ROOT CAUSE OF THE SUTURE TORN ISSUES. IN ADDITION, THE BAG WAS FOUND TO BE TORN AT PROXIMAL END; HOWEVER, THIS FINDING IS NOT RELATED TO THE INCIDENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECOMY PROCEDURE THE THREAD BROKE DURING USE OF THE DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPOUCH SPEC BAG LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1