BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL G2 ART CURV SEALER 35CM

    MDR report key: 11797604 · Received May 10, 2021

    Report

    Report Number
    3005075853-2021-02555
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    January 1, 2021
    Report Date
    April 15, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    UDI-DI
    10705036014508
    PMA / PMN Number
    K122797
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH #: U95C1E. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT PART OF THE DEVICE IS THE ¿TIP¿? AT THE END OF THE DEVICE DID THE ELECTRODE CERAMIC SEPARATE OR BREAK OFF? NO. DID THE I BLADE GET DAMAGED OR BREAK OFF? YES. IS THE JAW DAMAGED BUT NOT BROKEN OFF? NO. IS THE TOP JAW LOOSE BUT NOT DETACHED? NO. IS THE TOP JAW PTC MATERIAL DAMAGED? NO. IS THE BLACK PTC IN THE UPPER JAW DETACHED? NO. IS THE TOP JAW BROKEN OFF THE OF THE DEVICE? YES. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT/BATCH. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE IN A LAPAROSCOPIC LIVER RESECTION THE TIP OF THE DEVICE FELL OFF. ANOTHER DEVICE WAS OPENED AND USED. NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692081 ENSEAL G2 ART CURV SEALER 35CM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. NSLG2C35A U95C1E 10705036014508

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR