BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH 5MM CURVED

    MDR report key: 3181479 · Received June 21, 2013

    Report

    Report Number
    3005075853-2013-03167
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 25, 2013
    Report Date
    May 28, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K984240
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). END EFFECTOR. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: THE SURGEON WAS PERFORMING A VENTRAL HERNIA PROCEDURE AND THE CASE WAS GOING WELL. DURING DISSECTION IS WHEN HE NOTICED HALF THE JAW WAS MISSING. HE CLARIFIED THAT HE NEVER HEARD A SNAPPING NOISE AND IS UNSURE IF THE BREAK OCCURRED OUTSIDE OR INSIDE THE PATIENT. THE PATIENT RECOVERED FINE. THE ANALYSIS RESULTS CONFIRMED THAT ONE INSTRUMENT WAS RECEIVED WITH THE END EFFECTOR BROKEN AND RETURNED INSIDE A PLASTIC BAG. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. NO CONCLUSION COULD BE REACHED AS TO WHY THE END EFFECTOR OF THE DEVICE BROKE. IT SHOULD BE NOTED THAT 200% INSPECTIONS TAKE PLACE DURING THE MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; AND A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4). WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS FURTHER ANALYZED IT WAS CONFIRMED THAT THERE WAS NO MATERIAL OR PROCESSING DEFECTS OBSERVED IN THE MATERIAL. THE MOST PROBABLE CAUSE OF THE FRACTURE WAS TOO MUCH LOAD WAS APPLIED TO THE DISSECTOR DURING SURGERY THAT RESULTED IN THE DISSECTOR BREAKING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC HERNIA REPAIR PROCEDURE, WHILE THE SURGEON WAS PULLING DOWN SOME ADHESIONS HE HEARD A SNAP NOISE. THE SURGEON NOTICED THAT THE DEVICE WAS NOT WORKING AS WELL AS IT WAS BEFORE THE NOISE WAS HEARD. THE SURGEON PULLED THE DEVICE OUT OF THE PATIENT AND THE JAW HAD BROKEN OFF THE DEVICE AND INTO THE PATIENT. THE SURGEON LOOKED FOR THE PIECE LAPAROSCOPIC AND COULD NOT FIND THE PIECE OF THE DEVICE. X-RAY WAS BROUGHT INTO THE OR AND THE PIECE WAS FOUND AGAINST THE ABDOMINAL WALL. THE CASE WAS CONVERTED TO OPEN TO RETRIEVE THE PIECE OF DEVICE, JAW FROM THE PATIENT. THE CASE WAS COMPLETED WITH MESS AND SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281882 ENDOPATH 5MM CURVED ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. NA E4CE4U

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention