BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE*75MM LINEAR CUTTER

    MDR report key: 19656909 · Received July 2, 2024

    Report

    Report Number
    3005075853-2024-04863
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    April 12, 2024
    Report Date
    July 2, 2024
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036013211
    PMA / PMN Number
    K020779
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 7/2/2024. D4: BATCH #703C99. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON ENDO SURGERY FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT THE TLC75 DEVICE WAS RECEIVED WITH NO APPARENT DAMAGE, WITH A RELOAD LOADED IN THE DEVICE. THE RELOAD HAD THE PROXIMAL 15 DRIVERS UP WITHOUT STAPLES, THE REMAINING DRIVERS DOWN WITH STAPLES PRESENT AND WITH THE CARTRIDGE DECK DAMAGED. THE RETURNED RELOAD HAD THE SWING TAB IN THE LOCKED POSITION. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT, AND FORMED ALL THE STAPLES AS INTENDED. THE STAPLE LINE AND CUT LINE WERE COMPLETE, AND THE STAPLES MEET THE STAPLE FORM RELEASE CRITERIA. THE EVENT REPORTED WAS CONFIRMED AND IT IS RELATED TO IMPROPER USE OF THE DEVICE. IT SHOULD BE NOTED THAT THE CARTRIDGE RELOAD IS DESIGNED TO LOCKOUT, AS A SAFETY FEATURE, IF ANY STAPLES HAVE BEEN FIRED FROM THE CARTRIDGE RELOAD. IN ADDITION, FAILURE TO COMPLETE THE STROKE MAY RESULT IN INCOMPLETE STAPLE LINE. THE DAMAGE TO THE RELOAD IS CONSISTENT WITH THE DEVICE BEING CLAMPED OVER A HARD OBJECT. TO MITIGATE THE POTENTIAL FOR STAPLES GETTING INTO THE RELOAD AND INTERFERING WITH THE KNIFE DURING DEVICE FIRING, PRIOR TO RELOADING THE DEVICE, CLEAN IN STERILE SOLUTION AND THEN WIPE THE ANVIL AND RELOAD CHANNEL TO CLEAN ANY FORMED BUT UNUSED STAPLES FROM THE DEVICE. ADDITIONALLY, PROPER CARE SHOULD BE TAKEN WHEN PLACING THE DEVICE ON THE TISSUE TO BE STAPLED, TO ENSURE THAT NO HARD OBSTRUCTION SUCH AS A CLIP IS INCLUDED WITH THE TISSUE INSIDE THE JAWS. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR MORE INFORMATION. AS PART OF ETHICON ENDO SURGERY¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER 703C99, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS NOT POSSIBLE TO PUSH THE SCALPEL FORWARDS. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760872 PROXIMATE*75MM LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 710C17 10705036013211

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown