BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE RELOADABLE LINEAR STAPLER

    MDR report key: 122373 · Received September 25, 1997

    Report

    Report Number
    1527736-1997-02393
    Event Type
    Malfunction
    Date Received
    September 25, 1997
    Date of Event
    August 28, 1997
    Report Date
    August 28, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS AER LISTED BELOW: VISUAL INSPECTIONS & RESULTS: ANVIL POCKET CONDITION AB-GOOD, CARTRIDGE BATCH NUMBER A-K46957 B-K46L, CARTRIDGE CONDITION ABC-GOOD, CARTRIDGE POSITIONED PROPERLY AB-YES, CLOSURE TRIGGER POSITION AB-OPEN, DRIVER CONDITION ABC-GOOD, FIRING TRIGGER POSITION AB-OPEN, HANDLE SHROUD CONDITION AB-GOOD, HOOK/ANVIL CONDITION AB-GOOD, PROPER CARTRIDGE AB-YES, RETAINING PIN ARM CONDITION AB-GOOD, RETAINING PIN CONDITION ABC-GOOD, STAPLES PRESENT ABC-NO. FUNCTIONAL TESTS & RESULTS: CARTRIDGE LOCKOUT FUNCTIONAL AB-YES, CARTRIDGE REAR CAP PRESENT ABC-YES, CLOSURE STROKE FUNCTIONAL AB-YES, FIRING TRIGGER LOCKOUT FUNCTIONAL AB-YES, INSTRUMENT CYCLED AB-YES, PROPER CARTRIDGE GUIDE AB-YES, RELEASE BUTTON CONDITION AB-GOOD, STAPLES FIRE PROPERLY AB-YES, STAPLES FORM PROPERLY, TEST CARTRIDGE BATCH NUMBER AB-K47879, TRIGGER RELEASE CONDITION AB-YES. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, AND THE VISUAL AND FUNCTIONAL RESULTS, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THERE WERE TWO INSTRUMENTS AND THREE CARTRIDGES RETURNED. BOTH THE INSTRUMENTS AND CARTRIDGES WERE RECEIVED IN GOOD CONDITION. IT WAS NOTED THAT ALL THE DRIVERS ON ALL THREE OF THE CARTRIDGES WERE FULLY FORWARD. THE INSTRUMENTS WERE BOTH FIRED WITH RELOAD CARTRIDGES AND BOTH FIRED AND FORMED ALL THE STAPLES DESIGNED. THERE WERE NO ANOMOLIES NOTED WITH THE FORMATION OF STAPLES ON EITHER OF THE STAPLE LINES. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT IT FUNCTIONS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE TX60G WAS USED DURING A GASTRIC BYPASS. IT WAS REPORTED BY THE SCRUB NURSE THE STAPLES DID NOT LOOK RIGHT WHEN STAPLING THE STOMACH. IT WAS REPORTED THEY MIGHT HAVE FORMED, BUT THERE WAS NOT REAL TIGHT FORMATION AND THE DRIVERS DID NOT GO ALL THE WAY IN. A SECOND DEVICE WAS OPENED AND THE SAME THING HAPPENED. IT WAS REPORTED THE SURGEON STATED THE STAPLES LOOKED OK BUT THE SCRUB NURSE SAW MORE OF THE MALFORMED STAPLES. THE STOMACH MAY ALSO HAVE BEEN VERY THICK. THE REP IS RETURNING TWO DEVICES AND ONE RELOAD, XR60, LOT# K45248. A THIRD WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE RELOADABLE LINEAR STAPLER RELOADABLE LINEAR STAPLER GAG ETHICON ENDO-SURGERY, INC. NA K46Y8Z

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other