BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL G2 CURVED JAW

    MDR report key: 2994957 · Received March 8, 2013

    Report

    Report Number
    3005075853-2013-01155
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Report Date
    February 22, 2013
    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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO HAVE DEVICE RETURNED. DEVICE LOCATION IS UNKNOWN. THE DEVICE WAS NOT RECEIVED FOR ANALYSIS; THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED WITH A PIECE OF I BLADE BROKEN AND NOT RETURNED. TESTING FOUND A SHORT ON THE DEVICE, RESULTING IN A YELLOW MESSAGE SCREEN "REPOSITION JAWS AND REACTIVE" IS ADVISING THAT THE INSTRUMENT IS BEING ACTIVATED ON LOW IMPEDANCE (THIN) TISSUE OR METAL (SUCH AS STAPLES, CLIPS, RETRACTORS, OR CLAMPS). THE "REPLACE INSTRUMENT" SCREEN WOULD BE DISPLAYED AFTER RECEIVING THE "REPOSITION AND REACTIVATE" MESSAGE TWICE. THE INSTRUMENT WAS DISASSEMBLED. THE ACTIVE ROD INSULATION WAS SKIVED (INSULATION WAS SCRAPPED EXPOSING THE ACTIVE ROD) AT THE BUTT END OF THE ELECTRODE NEAR THE WELD. THE DAMAGE HAS EXPOSED THE SURFACE OF THE ACTIVE ROD AND ALLOWS CONTACT WITH THE UPPER JAW. THE CONTACT BETWEEN THE EXPOSED SURFACE OF THE ACTIVE ROD AND THE UPPER JAW CREATES AN ELECTRICAL SHORT PREVENTING THAT THE POWER DELIVERY FROM THE GENERATOR RESULTING IN AN ERROR CODE. THERE IS INSUFFICIENT EVIDENCE RELATED TO WHAT CAUSED THE DAMAGE; A PROBABLE CAUSE OF THE DAMAGE TO THE I-BLADE COULD BE NOT ALLOWING THICK AND FIBROUS TISSUES TO DENATURE PRIOR TO I-BLADE ADVANCEMENT.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMA PROCEDURE, THE INSTRUMENT DID NOT WORK AFTER A FEW TIMES. THE SURGEON MEANT THAT THE BLADE WAS DAMAGED. NO FURTHER INFORMATION IS AVAILABLE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100226 ENSEAL G2 CURVED JAW ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK J4CU7N

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR