BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSUTURE SUTURE

    MDR report key: 1974514 · Received January 31, 2011

    Report

    Report Number
    3005075853-2011-00360
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    December 15, 2010
    Report Date
    January 7, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K972679
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RECEIVED WITH THE SHAFT BENT; THEREFORE, NO TESTING COULD BE PERFORMED TO EVALUATE THE INCIDENT REPORTED. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC NISSEN PROCEDURE, ALL THE INFORMATION THAT WAS GIVEN IS ALL THREE DEVICES MISFIRED AND THE PATIENT HAD TO BE OPENED URGENTLY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. ONE DEVICE WILL BE RETURNED THE OTHER TWO DEVICES USED WERE DISCARDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSUTURE SUTURE LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA G4RN0C

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention