BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE RELOADABLE LINEAR STAPLER

    MDR report key: 3853085 · Received June 6, 2014

    Report

    Report Number
    3005075853-2014-03818
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    June 5, 2013
    Report Date
    January 7, 2014
    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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: LOCKOUT SLIDE TIP DAMAGED, DAMAGED ADJUSTING KNOB. THE ANALYSIS RESULTS SHOWED THAT THE TL60 DEVICE WAS RECEIVED IN GOOD VISUAL CONDITIONS AND WITH CARTRIDGE PRESENT ON THE DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE AND IT FORM THE STAPLES AS INTENDED AND WITH A PROPER B FORMATION. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE DEVICE WAS NOTED TO HAVE THE LOCKOUT TAB AND THE ADJUSTING KNOB DAMAGED. THE DAMAGE TO THE TAB AND KNOB IS CONSISTENT WITH AN EXCESSIVE FORCE APPLIED TO THE ROTATING KNOB WHEN TRYING TO DIAL DOWN A LOCKED DEVICE, CAUSING THE DAMAGE TO THE KNOB. IT SHOULD BE NOTED THAT THE INSTRUMENT HAS BEEN DESIGNED WITH A LOCKOUT FEATURE, WHICH DURING THE FIRST APPLICATION, PREVENTS TURNING THE ADJUSTING KNOB UNLESS THE RETAINING PIN IS PUSHED COMPLETELY FORWARD. PLEASE REFERENCE THE INSTRUCTIONS FOR USE FOR ADDITIONAL INFORMATION. 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 STAPLER DID NOT CLOSE. BY FORCING THE CLOSURE, TURNING THE UPPER VALVE THE PRODUCT BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332997 PROXIMATE RELOADABLE LINEAR STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA J4CJ96

    Patients

    Seq Age Sex Outcome Treatment
    1