BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHOLECYSTECTOMY TRAY

    MDR report key: 6411700 · Received March 16, 2017

    Report

    Report Number
    1527736-2017-00005
    Event Type
    Malfunction
    Date Received
    March 16, 2017
    Date of Event
    March 8, 2017
    Report Date
    March 8, 2017
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    PKE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # N9328G, N9320K, N9323W. PACKAGING LOT# N93487, MANUFACTURED DATE: 10/18/2016 PRODUCT EXP. DATE: 9/30/2021. PACKAGING LOT# N9353G, MANUFACTURED DATE: 10/19/2016 PRODUCT EXP. DATE: 9/30/2021. THE ANALYSIS RESULTS FOUND THAT THE LCB52S DEVICES WERE RETURNED OUTSIDE ITS ORIGINAL PACKAGE. ONLY THE DEVICES FROM THE CHOLECYSTECTOMY TRAY WERE RECEIVED. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSE THE REPORTED EVENT. THE LOT HISTORY RECORD WAS REVIEWED AND NO DEFECTS, NCR¿S OR PROTOCOLS RELATED TO THE COMPLAINT, WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT BEFORE AN UNKNOWN PROCEDURE, THE CUSTOMER FOUND A HOLE IN THE STERILE PACKAGING FOR THE ENTIRE TRAY. PROCEDURE WAS 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
    191197 CHOLECYSTECTOMY TRAY CHOLECYSTECTOMY TRAY PKE ETHICON ENDO SURGERY, INC (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1