BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL 5MM ROUND TIP 25CM

    MDR report key: 12615098 · Received October 12, 2021

    Report

    Report Number
    3005075853-2021-06107
    Event Type
    Malfunction
    Date Received
    October 12, 2021
    Date of Event
    April 2, 2021
    Report Date
    October 12, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    UDI-DI
    10705036000037
    PMA / PMN Number
    K072177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 11/8/2021. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON ENDO SURGERY FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT THE NSEAL525RH DEVICE WAS RECEIVED THE UPPER JAW DAMAGED AT THE PROXIMAL SIDE. THE DEVICE WAS CONNECTED TO THE GENERATOR AND IT WAS RECOGNIZED. BECAUSE THE JAW WAS DAMAGED NOT ALL FUNCTIONAL TESTING COULD BE PERFORMED WITH THE GENERATOR. THE CONDITION OF THE JAWS PREVENTED THE FUNCTIONALITY OF THE JAW. THE DEVICE WAS UNABLE TO CYCLE OPEN AND CLOSE. A PROBABLE CAUSE OF THE DAMAGE TO THE JAW COULD BE NOT ALLOWING THICK AND FIBROUS TISSUES TO DENATURE PRIOR TO I-BLADE ADVANCEMENT. AS DESCRIBED IN THE IFU: DO NOT USE EXCESSIVE FORCE ON THE CLOSING HANDLE TO CLOSE THE JAWS; GRASP ONLY AS MUCH TISSUE AS WILL FIT BETWEEN THE JAWS WHERE THE CURRENT WILL PASS. GREATER AMOUNTS OF TISSUE REQUIRE MORE CLOSING HANDLE FORCE. EXCESSIVE FORCE COULD DAMAGE THE DEVICE. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR MORE INFORMATION: AS PART OF ETHICON ENDO SURGERY¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE.

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH #: U95K1P. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DID THE ELECTRODE CERAMIC SEPARATE OR BREAK OFF? NO. DID THE I BLADE GET DAMAGED OR BREAK OFF? THE ACCOUNT IS NOT SURE 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? NO. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT/BATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EXPLORATORY LAPAROTOMY THE TIP BROKE OFF AND THE JAWS NO LONGER CLOSED. THE PROCEDURE WAS COMPLETED WITH A LIKE DEVICE WITH NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1515857 ENSEAL 5MM ROUND TIP 25CM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. NSEAL525RH U95K1P 10705036000037

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown GENERATOR| GENERATOR