BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL 5MM STANDARD TIP 45CM

    MDR report key: 1882604 · Received October 26, 2010

    Report

    Report Number
    3005075853-2010-06071
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    September 28, 2010
    Report Date
    October 7, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K072493
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). CHANGED INFORMATION. THE DEVICE WAS RECEIVED IN GOOD PHYSICAL CONDITION. THE DEVICE WAS TESTED WITH A GENERATOR AND THE DEVICE PERFORMED AS REQUIRED DURING TESTING. THE ENERGY OUTPUT DELIVERED FROM THE DEVICE WAS VERIFIED. THERE WERE NO ANOMALIES NOTED WITH THE FUNCTIONALITY OF THE DEVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED: WAS THE PROCEDURE OPEN, SINGLE SITE, ROBOTIC, ETC.? IT WAS A LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS. WERE THEY USING THE DEVICE IN SINGLE TAP OR DOUBLE TAP MODE. THE INSTRUMENT WAS BEING USED IN DOUBLE-TAP MODE AT THE TIME. DID THEY GET THE CONFIRMATION TONE FROM THE GENERATOR OR JUST THE CYCLE COMPLETE CHIRP, CHIRP AT THE END OF 15 SECONDS OR 2 MINUTES? BELIEVES HE WAS GETTING A COMPLETE TONE, DOESN'T REMEMBER FOR SURE. WAS THERE AN ACTUAL HEMOSTATIS /COAGULATION ISSUE OR DID THE DEVICE JUST NOT WORK, SUCH AS IT STOPPED ACTIVATING? . ENERGY WAS STILL ACTIVATING BUT NOT REALLY SEALING. IF THERE WAS A HEMOSTATIS ISSUES, HOW MUCH BLOOD WAS LOST? VERY LITTLE BLOOD LOSS. OCCURRED AT BEGINNING OF CASE AND SWITCHED OUT INSTRUMENT QUICKLY. IS THE SURGEON AN EXPERIENCED ENSEAL USER? IF YES, HOW MANY CASES? DR. (B)(6) HAS USED ENSEAL IN AT LEAST 500 CASES APPROXIMATELY HOW MANY TIMES HAD THEY FIRED THE INSTRUMENT DURING THE PROCEDURE? (E.G., WAS THIS EARLY IN THE PROCEDURE OR LATER? OCCURRED AT THE BEGINNING OF THE PROCEDURE. WAS THIS THE ONLY TIME DURING THE PROCEDURE THAT HEMOSTASIS WAS NOT ACHIEVED? INSTRUMENT WAS SWITCHED OUT FOR A NEW ONE, NO ISSUES AFTER THAT. WERE THEY GOING THROUGH TOUGH TISSUE? INSTRUMENT WAS BEING USED ON OMENTUM WHEN TROUBLE WITH VESSEL SEALING CAPABILITY WAS NOTICED. WAS THERE A REPLACE DEVICE WARNING (AUDIBLE BEEPS AND LIGHT)? DID NOT RECALL EXPERIENCING "REPLACE" LIGHT OR TONE. WAS EXCESSIVE GRASPING FORCE USED? DID NOT APPLY EXCESSIVE GRASPING FORCE. DID THE PATIENT HAVE PRIOR SURGERIES? (NO ANSWER). WAS A TRANSFUSION REQUIRED? NO BLOOD TRANSFUSION REQUIRED. HOW WAS BLOOD LOSS CONTROLLED? DESCRIBE HOW: USED SUTURE TO STOP BLEEDING. NOT MUCH BLEEDING BECAUSE IT WAS AN OMENTAL BLOOD VESSEL, BUT CLEAR THAT ENSEAL WASN'T SEALING PROPERLY WAS ANY MEDICAL INTERVENTION USED? (SUCH AS CONVERT TO OPEN TO CONTROL) NO MEDICAL INTERVENTION REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUX EN Y, GASTRIC BYPASS PROCEDURE, THE SURGEON WAS CUTTING THROUGH OMENTUM AND THE DEVICE WAS ACTIVATING FINE HOWEVER IT WAS NOT SEALING ANYTHING. THERE WAS BLEEDING HOWEVER THE AMOUNT OF BLOOD LOSS IS UNKNOWN. SUTURE WAS USED TO CONTROL THE BLEEDING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSEAL 5MM STANDARD TIP 45CM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR