BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL X1 CURVED 37CM SHAFT

    MDR report key: 11769909 · Received May 4, 2021

    Report

    Report Number
    3005075853-2021-02455
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    January 1, 2021
    Report Date
    April 9, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    UDI-DI
    10705036015468
    PMA / PMN Number
    K172580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH #: U94Z4X. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: IRREGULAR MOVEMENT OCCURRING IN/AROUND THE HARD PLASTIC COVER CONNECTING THE JAW TO THE SHAFT OF THE X1. NO FORCE CAN BE SET ON THE DEVICE DUE TO THIS MOVEMENT. WHAT PART OF THE DEVICE IS THE "PIVOT POINT"? THE HARD PLASTIC COVER CONNECTING THE JAW TO THE SHAFT OF THE X1. IS THE JAW DAMAGED? NO. DID THE ELECTRODE CERAMIC SEPARATE OR BREAK OFF? NO. DID THE I BLADE GET DAMAGED OR BREAK OFF? NO. 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. DID THE PATIENT SUFFER ANY ADVERSE CONSEQUENCES? NO. 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 REVEALED THAT THE NSLX137C DEVICE WAS RETURNED WITH THE DISTAL GUIDE WELD BROKEN. IN ADDITION, THE DEVICE WAS RECEIVED WITH KNIFE BLADE BENT. IT IS BELIEVED THAT THE KNIFE BECAME BENT AFTER THE KNIFE TRAVELED OUTSIDE THE KNIFE SLOT OF THE JAWS AND THE JAWS WERE CLOSED ON THE KNIFE, CREATING THE BEND. THE DEVICE WAS CONNECTED TO THE GEN11 AND IT WAS RECOGNIZED. HOWEVER, DUE TO THE CONDITION OF THE KNIFE ON THE DEVICE, NOT ALL FUNCTIONAL TEST COULD BE PERFORMED AS THE DEVICE RECEIVED A ¿REPOSITION REACTIVATE ERROR¿. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. AS PART OF ETHICON ENDO SURGERY¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. ALTHOUGH NO CONCLUSION COULD BE REACH ON THE CAUSE OF THE REPORTED EVENT, THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING CAUTION: THE ENSEAL X1 TISSUE SEALER INSTRUMENT IS A STERILE, SINGLE PATIENT USE SURGICAL INSTRUMENT TO COAGULATE AND TRANSECT VESSELS UP TO AND INCLUDING 7 MM IN DIAMETER, TISSUE AND/OR VASCULAR BUNDLES. THIS DEVICE IS FOR SOFT TISSUE ONLY. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP. SIGMOID RESECTION A KINK APPEARS TO OCCUR AT THE PIVOT POINT. IT OCCURRED WHEN THERE WASN'T MUCH FORCE OR TRACTION ON IT. THE INSTRUMENT WAS UNUSABLE AFTERWARDS. THERE ARE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664749 ENSEAL X1 CURVED 37CM SHAFT ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. NSLX137C 10705036015468

    Patients

    Seq Age Sex Outcome Treatment
    1