BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH STEALTH CIR STAPLER

    MDR report key: 2213992 · Received August 17, 2011

    Report

    Report Number
    3005075853-2011-03341
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Report Date
    July 25, 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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT AN ANVIL WAS RECEIVED IN GOOD VISUAL CONDITION AND WITHOUT AN INSTRUMENT. THE ANVIL WAS TESTED WITH A TEST ANCILLARY TROCAR AND FIT AS INTENDED. EVENT COULD NOT BE CONFIRMED AS THE ANCILLARY TROCAR WAS NOT RETURNED FOR ANALYSIS. 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, THEY COULD NOT GET THE ANCILLARY TROCAR TO GO INTO THE ANVIL. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH STEALTH CIR STAPLER CIRCULAR STAPLERS KOG ETHICON ENDO-SURGERY, LLC. NA G4UH3T

    Patients

    Seq Age Sex Outcome Treatment
    1