BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPOUCH RETRIEVER SPEC BAG

    MDR report key: 3870783 · Received June 12, 2014

    Report

    Report Number
    3005075853-2014-03959
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 17, 2014
    Report Date
    May 21, 2014
    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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4); DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DID ANY PART OF POUCH FALL INTO PATIENT? NO. WAS THERE ANY CHANGE TO PROCEDURE OR POST-OP PATIENT CARE AS RESULT OF BROKEN POUCH OR SPECIMEN SPILLING?] EXTRA TIME. NOT KNOW HOW LONG OF DELAY TO PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE SPECIMEN WAS CONTAINED AND WHEN THE SURGEON PULLED THE BAG, THE BAG BROKE FROM BELOW. THE SPECIMEN SPILLED FROM THE BAG, BUT ALL SPECIMEN "PIECES" WERE RETRIEVED. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347358 ENDOPOUCH RETRIEVER SPEC BAG LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1