BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENSEAL TRIO 3MM CURVE TIP 35 C

    MDR report key: 1933732 · Received December 21, 2010

    Report

    Report Number
    3005075853-2010-07282
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    December 8, 2010
    Report Date
    December 9, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K072177
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOID COLECTOMY PROCEDURE, THE DEVICE SEALED THE IMA AND THEN THE SEAL FAILED AND THE PATIENT STARTED BLEEDING INTRAOPERATIVELY. THEY HAD TO OPEN THE PATIENT TO CONTROL THE BLEEDING. THE CONVERT TO OPEN WAS A DIRECT RESULT FROM THE DEVICE NOT SEALING THE IMA. THE DOCTOR ALSO NOTED THAT THE DEVICE HAD A SIGNIFICANT AMOUNT OF STICKING IN THE JAWS AND HAD TO CONSTANTLY BE CLEANED THROUGHOUT THE CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION. HOWEVER, INITIAL ANALYSIS REVEALED A DEVICE ANOMALY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE IS INCLUDED IN THE SHORTENED REPLACEMENT WINDOW ADVISORY.

    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 Required Intervention GENERATOR