BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH STEALTH CIR STAPLER

    MDR report key: 2071732 · Received April 28, 2011

    Report

    Report Number
    3005075853-2011-01763
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 13, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED ANCILLARY TROCAR. THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITIONS AND VOID OF STAPLES. THE BREAKAWAY WASHER WAS PRESENT AND CUT. THE ANCILLARY TROCAR WAS INSPECTED VISUALLY AND SCRATCHES WERE NOTED ON THE COMPONENT. IT SHOULD BE NOTED THAT TO DETACH THE ANCILLARY TROCAR, IT SHOULD BE ROTATED 45 DEGREES IN THE ANVIL SHAFT SO THAT THE FINGER NOTCHES ARE PERPENDICULAR TO THE LOCKING SPRINGS (UNLOCKED POSITION). UTILIZING THE FINGER NOTCHES, PULL THE ANCILLARY TROCAR OUT OF THE ANVIL SHAFT. AFTER FURTHER ANALYSIS, IT WAS NOTED THAT THE LOCKING SPRINGS ON THE ANVIL WERE SCRATCHED, INDICATING THAT THE ANVIL WAS GRASPED BY THE LOCKING SPRINGS. PLEASE NOTE THAT IF THE LOCKING SPRINGS ARE CLAMPED, IT WILL NOT PERMIT THE CORRECT FUNCTIONALITY OF THE ANVIL LOCKING MECHANISM AND WILL LOCK THE ANCILLARY TROCAR IN THE ANVIL. WHEN ATTACHING OR DETACHING THE ANVIL, THE LOCKING SPRING SHOULD BE FREE TO MOVE; THEREFORE, THE ANVIL SHOULD NOT BE GRASPED BY THE LOCKING SPRINGS. 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. THE ANCILLARY TROCAR WAS INSERTED INTO THE ANVIL AND REMOVED AS INTENDED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE SURGEON TRIED TO FIT THE BLUE AUXILIARY TROCAR INTO THE ANVIL PORTION OF THE DEVICE. THE BLUE AUXILIARY TROCAR DID NOT FIT IN EASILY BUT DID EVENTUALLY FIT. ONCE THE ANVIL HAD BEEN POSITIONED, THE SURGEON ATTEMPTED TO POSITION THE AUXILIARY TROCAR. THIS WAS VERY DIFFICULT AND WAS ONLY REMOVED AFTER CONSIDERABLE FORCE. THE FEEDBACK WAS THAT THE AUXILIARY TROCAR MAY HAVE BEEN MOLDED INCORRECTLY AS THE SURGEON HAS USED THE DEVICE MANY TIMES AND THIS HAS NEVER BEEN AN ISSUE. ONCE THE AUXILIARY TROCAR WAS REMOVED, THE DEVICE FIRED CORRECTLY AND THE LEAK TEST SHOWED THAT THE ANASTAMOSIS WAS SECURE. PROCEDURE WAS PROLONGED 10 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH STEALTH CIR STAPLER CIRCULAR STAPLERS KOG ETHICON ENDO-SURGERY, LLC. NA G4UH6H

    Patients

    Seq Age Sex Outcome Treatment
    1