BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPOUCH RETRIEVER SPEC BAG

    MDR report key: 5132197 · Received October 7, 2015

    Report

    Report Number
    3005075853-2015-06310
    Event Type
    Malfunction
    Date Received
    October 7, 2015
    Date of Event
    September 15, 2015
    Report Date
    September 16, 2015
    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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS CONFIRMED THAT ONLY THE BAG FROM A POUCH DEVICE WAS RETURNED. UPON VISUAL EVALUATION, THE BAG WAS NOTED TO BE FULLY CINCHED AND TORN NEAR THE BOTTOM END (NOT AT THE SEAMS). THE TORN PORTION WAS NOTED STRETCHED. EACH DEVICE IS 100% VISUALLY INSPECTED PRIOR TO SHIPMENT AND DAMAGE OF THIS MAGNITUDE WOULD HAVE BEEN DETECTED DURING THIS INSPECTION. HOWEVER, A POTENTIAL CAUSE OF THE TORN BAG IS ATTEMPT TO REMOVE THE BAG WITH SPECIMEN THROUGH THE TROCAR OR FORCE THE BAG THROUGH THE ACCESS SITE AS THIS MAY LEAD TO BAG RUPTURE AND SPILLAGE OF CONTENTS. THE FOLLOWING OPTIONS ARE RECOMMENDED IN ORDER TO AVOID THIS KIND OF ISSUE: REMOVE THE INSTRUMENT, SPECIMEN BAG, AND TROCAR TOGETHER FORM THE ACCESS SITE (DO NOT PULL THE SLIP KNOT). REMOVE THE INSTRUMENT FROM THE TROCAR, FOLLOWING BY THE SPECIMEN BAG WITH THE TROCAR. REMOVE THE INSTRUMENT, TROCAR AND SPECIMEN BAG SEPARATELY FROM THE ACCESS SITE. IF THE BAG WITH THE SPECIMEN CANNOT BE REMOVED THROUGH THE ACCESS SITE, CAREFULLY ENLARGE THE ACCESS SITE TO FACILITATE EASY BAG REMOVAL. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC OOPHORECTOMY PROCEDURE, THE POUCH BROKE NEAR BOTTOM OF BAG (NOT THE SEAM) WHILE REMOVING THE SPECIMEN. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663359 ENDOPOUCH RETRIEVER SPEC BAG LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA M4HU3Z

    Patients

    Seq Age Sex Outcome Treatment
    1