BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPOUCH RETRIEVER SPEC BAG

    MDR report key: 1813232 · Received August 6, 2010

    Report

    Report Number
    3005075853-2010-04477
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 19, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: THE ANALYSIS RESULTS OF THE POUCH FOUND THAT IT WAS RECEIVED WITH THE SUTURE CUT. DURING EVAL THE BAG WAS NOTED TORN AT THE BOTTOM END (NOT AT THE SEAMS). THE TORN PORTION WAS NOTED STRETCHED. EACH DEVICE IS 100% VISUALLY INSPECTED AT TWO DIFFERENT ASSEMBLY OPERATIONS 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 FROM 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. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE BAG BROKE WHEN THE SURGEON WAS TAKING THE GALL BLADDER OUT OF THE ABDOMEN. THE CONTENTS FELL INTO THE PT. THE CONTENTS WERE RETRIEVED WITH SEVERAL PASSES USING A LAPAROSCOPIC STONE RETRIEVAL INSTRUMENT. THE PROCEDURE WAS PROLONGED BY 15 MINUTES. THE LAPAROSCOPIC STONE RETRIEVAL DEVICE AND ADD'L IRRIGATION AND SUCTION WERE USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1