BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL TRIO 3MM CURVE TIP 35 C

    MDR report key: 1933788 · Received December 21, 2010

    Report

    Report Number
    3005075853-2010-07290
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    December 13, 2010
    Report Date
    December 14, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K072177
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRECTOMY PROCEDURE, ALTHOUGH THE DEVICE WAS ACTIVATED PROPERLY AT THE BEGINNING, IT HAD A DIFFICULTY IN SEALING THE TARGET TISSUE. BESIDES, THE TARGET TISSUE BEGAN TO STICK TO THE JAW. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. DEVICE DISCARDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED: WAS THERE AN ACTUAL HEMOSTASIS /COAGULATION ISSUE OR DID THE DEVICE JUST NOT WORK, SUCH AS IT STOPPED ACTIVATING? ---IT WAS HEMOSTASIS ISSUE. IF THERE WAS A HEMOSTASIS ISSUES, HOW MUCH BLOOD WAS LOST? --- NO DETAILED INFORMATION. BUT THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. WAS THE PROCEDURE OPEN, SINGLE SITE, ROBOTIC, ETC.? ---LAPAROSCOPIC. WERE THEY USING THE DEVICE IN SINGLE TAP OR DOUBLE TAP MODE. ---NO INFORMATION. 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? ---NO INFORMATION. IS THE SURGEON AN EXPERIENCED ENSEAL USER? ---NO. THE SURGEON WAS LIGASURE USER AND HE/SHE USED ENSEAL FOR THE FIRST TIME. IF YES, HOW MANY CASES? ---N/A. APPROXIMATELY HOW MANY TIMES HAD THEY FIRED THE INSTRUMENT DURING THE PROCEDURE? (E.G., WAS THIS EARLY IN THE PROCEDURE OR LATER? ---THIS HAPPENED A FEW TIMES FROM THE BEGINNING TO THE LAST. WAS THIS THE ONLY TIME DURING THE PROCEDURE THAT HEMOSTASIS WAS NOT ACHIEVED? ---NO. WERE THEY GOING THROUGH TOUGH TISSUE? --- NO INFORMATION. WAS THERE A REPLACE DEVICE WARNING (AUDIBLE BEEPS AND LIGHT)? --- NO. WAS EXCESSIVE GRASPING FORCE USED? --- NO INFORMATION. DID THE PATIENT HAVE PRIOR SURGERIES? --- NO INFORMATION. WAS A TRANSFUSION REQUIRED? ---NO. HOW WAS BLOOD LOSS CONTROLLED? DESCRIBE HOW: --- ASTRICTION WAS PERFORMED WITH GAUZE. WAS ANY MEDICAL INTERVENTION USED? (SUCH AS CONVERT TO OPEN TO CONTROL) --NO. WAS THE CONVERT TO OPEN A DIRECT RESULT OF THE LACK OF COAGULATION? ---N/A. WHAT WAS THE SIZE OF THE VESSEL OR ARTERY? ---NO INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSEAL TRIO 3MM CURVE TIP 35 C ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR