BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX

    MDR report key: 1972846 · Received January 28, 2011

    Report

    Report Number
    3005075853-2011-00334
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 2, 2011
    Report Date
    January 3, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). INSTRUMENT B: PINION AXLE SUPPORT. THE ANALYSIS RESULTS FOUND THAT THE ATS45 DEVICE (A) WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO RELOAD PRESENT ON THE DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE, THE CUT LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. EVENT COULD NOT BE CONFIRMED AS NO CARTRIDGE WAS RECEIVED FOR ANALYSIS. IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN (B)(4), AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE. THE ANALYSIS RESULTS FOUND THAT THE ATS45 DEVICE WAS RETURNED WITH THE FIRING MECHANISM DAMAGED AND WITH NO RELOAD PRESENT. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE LEFT SHROUD PINION AXLE SUPPORT WAS FOUND DAMAGED. WHILE NO CONCLUSION COULD BE REACH WHAT CAUSE THE FIRING MECHANISM TO FAIL, IT IS POSSIBLE THAT THE DEVICE WAS FIRED ON TISSUE THICKER THAN INDICATED OR THROUGH A LOCKED CARTRIDGE. WHEN EITHER OR BOTH OF THESE SCENARIOS OCCUR THE COMPONENTS IN THE FIRING MECHANISM CAN BE DAMAGED. IT SHOULD BE NOTED THAT A 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; (B)(4). NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT, AS THERE WAS NO RELOAD RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    THE PROCEDURE WAS A LAPAROSCOPIC APPENDECTOMY. HALF THE STAPLES CAME DOWN AND THE BLADE DID NOT CUT. THERE WERE NO PATIENT CONSEQUENCES. ANOTHER DEVICE WAS USED AND THE SAME THING HAPPENED HALF THE STAPLES CAME DOWN AND THE BLADE DID NOT CUT. THE SECOND DEVICE WAS RELOADED AND THE DEVICE FINALLY WORKED. THE CALLER MENTIONED THAT SHE IS NOT SURE IF THE ISSUE WAS USER ERROR. THE SURGEON'S NAME IS DR. (B)(6). THE 2 DEVICES WILL BE RETURNED HOWEVER AN UNKNOWN NUMBER OF RELOADS WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS FLEX STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4U56E

    Patients

    Seq Age Sex Outcome Treatment
    1