BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** ETS FLEX45

    MDR report key: 2862260 · Received December 7, 2012

    Report

    Report Number
    3005075853-2012-05511
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 11, 2012
    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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE AFFILIATE. DAMAGED FIRING TRIGGER TEETH. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 8TH, ETC.) 1ST. WHAT COLOR CARTRIDGE WAS BEING USED? UNK. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? NO. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO EXISTING STAPLE LINE. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING? NO. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? NO. IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? NO. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED WITH THE FIRING MECHANISM DAMAGED AND WITH NO RELOAD PRESENT. THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES NOTED. 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 FIRING TRIGGER TEETH WERE FOUND BROKEN. WHILE NO CONCLUSION COULD BE REACHED OF 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; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4). NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT, AS THERE WAS NO RELOAD RETURNED FOR ANALYSIS. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE COULD NOT FIRE DURING THE PROCEDURE. IT WAS DIFFICULT TO OPEN. CHANGED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. NO ADVERSE EVENT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** ETS FLEX45 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4TC9U

    Patients

    Seq Age Sex Outcome Treatment
    1