BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL G2 STRAIGHT JAW

    MDR report key: 2872221 · Received December 13, 2012

    Report

    Report Number
    3005075853-2012-05686
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 28, 2012
    Report Date
    December 7, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K112033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE DEVICE WAS RETURNED WITH I- BLADE CRACKED, JAW DETACHED (RETURNED) AND CABLE CUT. THE INSTRUMENT COULD NOT BE TESTED BY GENERATOR DUE TO THE RETURNED CONDITIONS OF THE DEVICE. THERE IS INSUFFICIENT EVIDENCE RELATED TO WHAT CAUSED THE BENT JAW; A PROBABLE CAUSE OF THE DAMAGE TO THE JAWS COULD BE NOT ALLOWING THICK AND FIBROUS TISSUES TO DENATURE PRIOR TO I-BLADE ADVANCEMENT

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE TOP AND BOTTOM JAW SEPARATED FROM THE DEVICE THEN FELL INTO THE PATIENT. THE JAW WAS RETRIEVED. THE JAW WAS VISUALLY ABLE TO BE SEEN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED. ONE DEVICE AND JAW WILL BE RETURNED. NO OTHER DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSEAL G2 STRAIGHT JAW ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK J4C209

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR