BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPT SLEEVE 12X100 STABILITY

    MDR report key: 9113950 · Received September 24, 2019

    Report

    Report Number
    3005075853-2019-22316
    Event Type
    Malfunction
    Date Received
    September 24, 2019
    Date of Event
    September 2, 2019
    Report Date
    September 4, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    UDI-DI
    10705036001188
    PMA / PMN Number
    K122512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH # T93D3A. INVESTIGATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT 2CB12LT DEVICE WAS RECEIVED WITH THE UNIVERSAL SEAL CAP SEPARATED FROM THE UNIVERSAL SEAL BASE. IN ADDITION, THE TYVEK WAS RETURNED ALONG WITH THE INSTRUMENT. DURING VISUAL EXAMINATION, DEVICE WAS NOTED TO HAVE INSUFFICIENT WELDING RESULTING IN THE UNIVERSAL SEAL CAP AND THE UNIVERSAL SEAL BASE BEING SEPARATED, THE INNER SEAL ASSEMBLY IS OUT OF POSITION, AND HAVE EVIDENCE OF NOT BEING PROPERLY WELDED DURING THE MANUFACTURING PROCESS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH # T93D3A. BRAND NAME IS OPT SLEEVE 12X100 STABILITY. CATALOG NUMBER IS 2CB12LT. UNIQUE IDENTIFIER( UDI) IS (B)(4). PMA/ 510(K) IS K122512.

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER T40K8L AND NO NON-CONFORMANCES WERE IDENTIFIED. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SEMI-OPEN UNKNOWN PROCEDURE, THE VALVE CAME OFF THE SLEEVE DURING USE, SO THE DEVICE COULD NOT BE USED. THE SURGEON REMOVED ALL PIECES WITHOUT CONVERTING TO LAPAROTOMY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907852 OPT SLEEVE 12X100 STABILITY LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. T40K8L 10705036001188

    Patients

    Seq Age Sex Outcome Treatment
    1