BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC ARTICULATING MULTIFEED STAPLER

    MDR report key: 82273 · Received February 20, 1997

    Report

    Report Number
    1527736-1997-00070
    Event Type
    Malfunction
    Date Received
    February 20, 1997
    Report Date
    February 20, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON THE INQUIRY INFO REC'D, THE VISUAL EXAMINATION AND THE FUNCTIONAL TEST, IT WAS CONCLUDED THAT THE INSTRUMENT WAS CONFORMING WITH REGARD TO STAPLES FEEDING, FIRING AND FORMING. THE INSTRUMENT WAS EXAMINED, WAS FOUND TO BE FUNCTIONAL, AND WAS CYCLED, FIRED AND PROPERLY FORMED THE REMAINING 12 STAPLES WITHOUT INCIDENT. NO CONCLUSION COULD BE REACHED AS TO WHY THE REPORTED INSTRUMENT "WOULD NOT FIRE AND THE STAPLES WOULD NOT COME OUT" DURING SURGERY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT STAPLES FEED, FIRE AND FORM CORRECTLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.

    Description of Event or Problem · 1

    DURING AN UNK PROCEDURE THE EAS WOULD NOT FIRE AND THE STAPLES WOULD NOT COME OUT. ANOTHER EAS WAS USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT. CLINICAL FOLLLOW UP: 1/29/97 1347 SPOKE TO CONTACT PERSON WHO CONFIRMED THE INFO AS REPORTED BY THE REP. SHE STATED THIS OCCURRED ON THE FIRST FIRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC ARTICULATING MULTIFEED STAPLER ENDOSCOPIC STAPLER GAG ETHICON ENDO-SURGERY, INC. NA J4259F

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other