BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL TRIO 3MM CURVE TIP 35 C

    MDR report key: 1900973 · Received November 17, 2010

    Report

    Report Number
    3005075853-2010-06569
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 4, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K072177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT ONE (1) CE INTERMATE LV 50 DEVICE WAS OBSERVED LEAKING AT THE LOCATION OF THE BLUE WINGED CAP. THE DEVICE WAS FILLED WITH 90MG OF PAMIDRONATE IN 250ML 0.9% SODIUM CHLORIDE. THE PRODUCT WAS NOT ADMINISTERED TO THE PATIENTS. THE LEAK WAS NOTED PRIOR TO PRODUCT USE AND THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. THIS IS REPORT 10 OF 17 WITH THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY PROCEDURE, THE JAWS OF THE DEVICE WILL NOT OPEN ALL THE WAY. THE DEVICE WAS USED ON THE INFUNDIBULAR PELVIC LIGAMENT HOWEVER THE DEVICE WAS NOT STUCK ON TISSUE. 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 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