BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL 5MM ROUND TIP 35CM

    MDR report key: 1862212 · Received October 8, 2010

    Report

    Report Number
    3005075853-2010-05777
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    August 9, 2010
    Report Date
    September 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDED ADDITIONAL 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

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE GETS HEMOSTASIS ISSUE. ANOTHER DEVICE LIKE DEVICE WAS USED TO COMPLETE THE CASE. REQUESTED ADDITIONAL INFORMATION, BUT NOT YET RECEIVED.

    Description of Event or Problem · 1

    THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE DOES NOT TURN ON WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSEAL 5MM ROUND TIP 35CM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK G4T64W

    Patients

    Seq Age Sex Outcome Treatment
    1