BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*ILS CURVED CIR STAPL

    MDR report key: 1883102 · Received October 26, 2010

    Report

    Report Number
    3005075853-2010-06089
    Event Type
    Injury
    Date Received
    October 26, 2010
    Date of Event
    September 29, 2010
    Report Date
    October 8, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE AFFILIATE. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION RECEIVED ON 10/13/2010: REVISED INFORMATION: [PROCEDURE/SURGERY NAME]: OPEN TOTAL GASTRECTOMY. THE DEVICE WAS USED FOR ESOPHAGOJEJUNOSTOMY WITH SINGLE STAPLING TECHNIQUE. THE DOCTOR FELT A DIFFICULTY IN FIRING. ALTHOUGH LEAK TEST PERFORMED, THE ANASTOMOSIS SITE SEEMED TO BE NO PROBLEM. JUST TO BE SAFE, A PART OF THE SITE WAS SUTURED BY HAND TO COMPLETE THE CASE. WHEN THE PATIENT WAS DELIVERED TO THE HOSPITAL WARD, THE DOCTOR CONFIRMED THE MANY CONTENTS FROM THE DRAINAGE. SO, THE DOCTOR JUDGED THAT MAJOR LEAK OCCURRED FROM THE SITE. THE RE-OPERATION WAS PERFORMED ON THE SAME DAY AND THE DOCTOR CONFIRMED THAT ALL STAPLES OF THE ANASTOMOSIS SITE SEEMED TO BE MALFORMED AND ACRAL PART OF THE ALL STAPLES SEEMED TO BE SLIGHTLY BENT. ANOTHER COMPETITOR'S DEVICE WAS USED TO COMPLETE THE CASE. THE PATIENT WAS GETTING WELL. WE HAVE NO DETAILED INFORMATION ABOUT THE EXACT TIME THAT THE REOPERATION WAS PERFORMED AFTER THE OPERATION. THE DOCTOR COMMENTED AS BELOW. THE TISSUE WAS THIN AND THE TISSUE WAS DISTRIBUTED EVENLY. THE LOCATION OF THE INDICATOR WAS WITHIN UPPER THAN MIDDLE POSITION OF THE GAP SETTING SCALE. THE DEVICE DID NOT FIRE ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP. THE DOCTOR COULD NOT CONFIRM THE WASHER'S CRUNCH AND THE FEEL WHEN THE DEVICE WAS FIRED. THERE WERE NOT DIFFICULTIES IN REMOVING THE DEVICE. THE DOUGHNUTS WERE PROPER. THE STAPLES FORMATION COULD NOT CONFIRM ALTHOUGH X-RAY WAS PERFORMED AFTER THE OPERATION. REQUESTED ADDITIONAL INFORMATION AND RECEIVED THE FOLLOWING RESPONSE ON 10/15/2010: IN ADDITION TO THE DRAINAGE NOTICED BY THE SURGEON, DID THE PATIENT HAVE ANY OTHER SYMPTOMS AS A RESULT OF THIS EVENT? SORRY, WE HAVE NO DETAILED INFORMATION ABOUT THE PATIENT'S CONDITION. AS MANY CONTENTS FROM THE DRAINAGE LEAKED, THE DOCTOR JUDGED THAT MAJOR LEAK OCCURRED FROM THE SITE AND THEN REOPERATION WAS PERFORMED. DID THE PATIENT HAVE A HISTORY OF RECEIVING RADIATION OR CHEMOTHERAPY? SORRY, WE HAVE NO DETAILED INFORMATION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). WASHER UNCUT THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION WITHOUT STAPLES PRESENT AND WITH THE BREAKAWAY WASHER UNCUT AND INDENTED, INDICATING THAT THE DEVICE HAD NOT BEEN FIRED THROUGH A FULL FIRING STROKE OR POSSIBLY THAT THE ORANGE INDICATOR WAS NOT FULLY INTO THE SAFE GREEN FIRING RANGE. IT SHOULD BE NOTED THAT IF THE INDICATOR IS NOT FULLY WITHIN THE GREEN RANGE OF THE GAP SETTING SCALE OR IF THE FIRING HANDLE IS NOT FIRMLY SQUEEZED USING STEADY PRESSURE UNTIL THE FIRING HANDLE IS FULLY PARALLEL TO THE INSTRUMENT HANDLE, STAPLES COULD BE DEPLOYED WITHOUT COMPLETELY FORMING AND WITHOUT CUTTING THE WASHER. FOR MORE INFORMATION, PLEASE REFER TO THE INSTRUCTIONS FOR USE. THE DEVICE WAS RELOADED WITH STAPLES AND TESTED FOR FUNCTIONALITY WITH A TEST WASHER; THE DEVICE FORMED ALL THE STAPLES, AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SIGMOIDECTOMY PROCEDURE, THE DOCTOR FELT A DIFFICULTY IN FIRING THE DEVICE. ADDITIONAL SUTURE WAS PERFORMED AND THE CASE WAS COMPLETED. HOWEVER, WHEN THE ABDOMINAL CAVITY WAS REOPENED AT THE REOPERATION, IT WAS FOUND THAT THE STAPLES WERE NOT DEPLOYED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE LOCKED ON TISSUE THEN WAS REMOVED BY PULLING IT FROM TISSUE. THERE WAS MINIMAL TISSUE DAMAGE AND CLIPS WERE ABLE TO BE PLACED AROUND THE TEAR. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE*ILS CURVED CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other| R