BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETRIO

    MDR report key: 2243433 · Received September 12, 2011

    Report

    Report Number
    3005075853-2011-03746
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K072177
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDED ADDITIONAL INFORMATION THE DEVICE WAS RECEIVED IN GOOD CONDITION. THE DEVICE WAS TESTED WITH A 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. THERE WERE NO HEAT ISSUES DURING ANY FUNCTIONAL TESTING. THERE WERE NO ANOMALIES NOTED WITH THE FUNCTIONALITY OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. ADDITIONAL INFORMATION: THE CASE WAS A COLORECTAL PROCEDURE: PERINEAL PROCTECTOMY. THIS PROCEDURE IS DONE WHEN A PATIENT HAS RECTAL PROLAPSE. THIS SURGEON WOULD HAVE BEEN REMOVING THE REDUNDANT RECTUM EVEN IF THE PATIENT¿S ANAL DERM (SKIN OF THE ANAL CANAL) HADN¿T BEEN BURNT. SURGEON WOULD ALSO STILL HAVE USED A CIRCULAR STAPLER TECHNIQUE AS WELL. THE TECHNIQUE IS JUST LIKE A LAP PROCEDURE IN A LOW ANTERIOR RESECTION EXCEPT FOR INSTEAD OF BEING IN THE BODY, THE SURGEON IS DOING IT THROUGH THE ANUS. THE SURGEON PULLS THE EXCESS COLON OUT OF THE ANUS AND TRANSECTS IT. SURGEON USED THE DEVICE TO TRANSECT ATTACHMENTS TO GAIN FURTHER EXPOSURE AND TAKE DOWN THE REDUNDANT RECTUM. ONCE SURGEON GAINED ADEQUATE LENGTH ON THE REDUNDANT RECTUM, SHE TRANSECTED IT WITH THE DEVICE. DURING THIS TRANSECTION, HER FINGERS ARE RIGHT NEXT TO THE DEVICE DUE TO THE LIMITED SPACE. SEVERAL TIMES THE HEAT BECAME SO INTENSE THAT SHE HAD TO LET GO. THE GLOVE OF THE DOCTOR WAS NOT BURNT THROUGH. THE PATIENT¿S ANAL DERM WAS ALSO BURNT DURING THIS PART OF THE PROCEDURE. AREA WAS INITIALLY BLANCHED WHITE AND LATER LOOKED A LITTLE LESS WHITE, HOWEVER THAT TISSUE IS VERY PINK TO BEGIN WITH. SURGEON TOLD REP THAT BEING ABLE TO HAVE HER HAND SO CLOSE TO THE DEVICE IS ONE OF THE PRIMARY REASONS SHE LIKES TO USE IT. SHE FEELS THAT IT IS A VERY SAFE DEVICE.

    Description of Event or Problem · 1

    THE SALES REP REPORTS THAT DURING A PERINEAL PROSTATECTOMY PROCEDURE, THE DEVICE WAS GETTING HOTTER THAN NORMAL. THE SURGEON WAS TRANSECTING THE REDUNDANT RECTUM. THE DEVICE BURNED THROUGH THE SURGEON'S GLOVE AND THE PATIENT'S ANALDERM GOT BURNT. THE SURGEON USED A PURSE SUTURE AND CIRCULAR STAPLER TO REATTACH THE GOOD PART OF THE RECTUM, REMOVED THE REDUNDANT PART AND REATTACHED THE ANUS. AFTERWARDS THE SURGEON TREATED THE PATIENT'S BURN WITH SALVE. PER THE SURGEON, THE PATIENT WILL BE IN PAIN FROM THE BURN. THE PATIENT IS CURRENTLY OKAY. TWO AREAS WERE ABOUT 1CM DIAMETER AND 2ND DEGREE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETRIO ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK H43X3E

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GENERATOR AND HANDPIECE