BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPOUCH RETRIEVER SPEC BAG

    MDR report key: 2990019 · Received March 5, 2013

    Report

    Report Number
    3005075853-2013-01041
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT INDICATED THAT THE PACKAGING DIDN'T FEEL SECURE WHEN THE NURSE STARTED TO PEEL IT OPEN. THE PACKAGE WAS RETURNED OPEN AND A HANDWRITTEN NOTE WAS ON THE LID. THE PACKAGE WAS VISUALLY EXAMINED AND IT WAS NOTED THAT THE AREA WHERE THE PACKAGE WAS OPENED DID HAVE SEAL ADHESIVE TRANSFER AROUND ENTIRE FLANGE ON THE BLISTER INDICATING THAT THE PACKAGE HAD BEEN COMPLETELY SEALED PRIOR TO BEING OPENED. THE PACKAGE WAS PEELED OPEN ON THE REST OF THE PACKAGE TO VERIFY SEAL. SEALED PACKAGE FELT NORMAL AND SECURE. IT CANNOT BE DETERMINED AT WHAT POINT THE PACKAGE WAS OPENED. COMPLAINT EVENT COULD NOT BE VERIFIED. LOT HISTORY RECORDS WERE REVIEWED. NO PROTOCOLS, DEFECTS, NON-CONFORMANCES OR QUARANTINE NOTED. THE PRODUCT MET ALL IN-PROCESS AND FINISHED GOODS SPECIFICATIONS UPON RELEASE OF THE PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY PROCEDURE, UPON THE NURSE STARTING TO PEEL THE BAG OPEN SO NOTED THAT THE PACKAGING DIDN'T FEEL SECURE. THERE WERE NO PATIENT CONSEQUENCES. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93034 ENDOPOUCH RETRIEVER SPEC BAG LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA J4CM4T

    Patients

    Seq Age Sex Outcome Treatment
    1