BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL SUPER JAW

    MDR report key: 2862462 · Received December 10, 2012

    Report

    Report Number
    3005075853-2012-05520
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 15, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION DEVICE A WAS RECEIVED IN GOOD CONDITION. THE DEVICE WAS TESTED ON THE GENERATOR AND PASSED ALL FUNCTIONAL TESTING. THE ENERGY OUTPUT DELIVERED FROM THE DEVICE WAS VERIFIED AND THE CUTTING OF THE TEST MEDIA PERFORMED AS EXPECTED. ALL THREE TONES WERE HEARD DURING FUNCTIONAL TESTING (TONE 1 IS HEARD WHEN THE ENERGY ACTIVATION BUTTON IS PRESSED; TONE 2 IS HEARD WHEN TISSUE IMPEDANCE THRESHOLD IS REACHED; AND TONE 3 IS HEARD WHEN THE CYCLE IS COMPLETE). DURING FUNCTIONAL TESTING, THE JAWS OPENED AND CLOSED WITH THE KNIFE ADVANCING AND RETRACTING PROPERLY. THERE WERE NO ANOMALIES NOTED WITH THE FUNCTIONALITY OF THE DEVICE. DEVICE B WAS RECEIVED WITH TISSUE IN THE JAWS. DURING MECHANICAL TESTING, THE BLADE DID NOT RETURN AFTER THE HANDLE WAS DEPRESSED AND THE JAW DID NOT OPEN. THE JAWS WERE OPENED BY APPLYING AN OPENING FORCE ON THE HANDLE WITH TWO HANDS. DUE TO THE BUCKLED KNIFE, FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE KNIFE BLADE WAS BUCKLED WHICH RESULTED IN THE JAWS NOT OPENING. DEVICE B BATCH H92T0D, MFG DATE: 11/29/2011, EXP DATE: 10/29/2013.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION NOT ASKED FOR BUT UNKNOWN OR PROVIDED DURING INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VAGINAL HYSTERECTOMY PROCEDURE, THE JAW WOULD NOT OPEN BOTH TIMES ON THE TISSUE ONCE FIRED. THERE WERE NO PATIENT CONSEQUENCES. CASE COMPLETED BY HAND TIE. TWO DEVICES WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSEAL SUPER JAW ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK H44YOU

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR