BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH STEALTH CIR STAPLER

    MDR report key: 1981115 · Received February 8, 2011

    Report

    Report Number
    3005075853-2011-00492
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Report Date
    January 19, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    KOG
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION: REP VISITED AND WAS PRESENTED WITH THE DEVICE IN A BAG FROM A SURGERY PERFORMED SIX MONTHS AGO. THE BAG HAD A NOTE WITH LITTLE INFORMATION. THE REP SPOKE TO THE SURGEON AND SHE ONLY REMEMBERS THAT SHE HAD PROBLEMS ATTACHING THE ANVIL TO THE TROCAR BUT FINALLY HEARD A SNAP AND FIRED THE DEVICE SUCCESSFULLY. THE SURGEON HAS HAD NO ISSUES WITH THE DEVICE IN THE SURGERIES SHE HAS PERFORMED RECENTLY.

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED ANVIL FORMER. THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITIONS AND FULLY LOADED WITH STAPLES. THE BREAKAWAY WASHER WAS PRESENT AND CUT. AFTER FURTHER ANALYSIS, IT WAS NOTED THAT THE LOCKING SPRINGS ON THE ANVIL WERE SCRATCHED, INDICATING THAT THE ANVIL WAS NOT ATTACHED CORRECTLY. IT SHOULD BE NOTED THAT WHEN ATTEMPTING TO ATTACH THE DETACHABLE HEAD OR ANVIL, DO NOT CLAMP ACROSS OR GRIP ON THE LOCKING SPRINGS AS IT MIGHT NOT CLICK INTO PLACE. WHEN THIS HAPPENS, THE ANVIL WILL NOT SIT CORRECTLY/COMPLETELY IN THE DEVICE, RESULTING IN A BIGGER GAP BETWEEN THE ANVIL AND GUIDE FACE. THEREFORE, THE STAPLES WILL NOT HIT THE ANVIL TO MAKE A B-FORM STAPLE. PLEASE REFERENCE THE INSTRUCTIONS FOR USE FOR ADDITIONAL INFORMATION. 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. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC ROUX-EN-Y PROCEDURE, THE SURGEON WAS USING THE DEVICE DOWN THE ESOPHAGUS AND DURING PLACEMENT, COULD NOT GET THE ANVIL TO CONNECT AND SNAP INTO PLACE WITHOUT THE USE OF A GRASPER. THE SURGEON FINALLY MANAGED TO GET THE ANVIL AND THE TROCAR TOGETHER AND FIRED SUCCESSFULLY. THE DEVICE CUT AND STAPLED PROPERLY. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH STEALTH CIR STAPLER CIRCULAR STAPLERS KOG ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1