BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE RELOADABLE LINEAR STAPLER

    MDR report key: 95365 · Received May 30, 1997

    Report

    Report Number
    1527736-1997-01096
    Event Type
    Malfunction
    Date Received
    May 30, 1997
    Date of Event
    April 10, 1997
    Report Date
    May 29, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY EXPERIENCED AN EVENT WITH PROXIMATE* RELOADABLE LINEAR STAPLER ON 4/10/97 WHILE PERFORMING A THORACOTOMY. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY # 972316. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: ANVIL POCKET CONDITION, GOOD; CARTRIDGE BATCH NUMBER, J00F7U; CARTRIDGE CONDITION, GOOD; CARTRIDGE POSITIONED PROPERLY, YES; CLOSURE TRIGGER POSITION, OPEN; DRIVER CONDITION, GOOD; FIRING TRIGGER POSITION, OPEN; HANDLE SHROUD CONDITION, GOOD; HOOK/ANVIL CONDITION, GOOD; PROPER CARTRIDGE, YES; RETAINING PIN ARM CONDITION, GOOD; RETAINING PIN CONDITION, GOOD AND STAPLES PRESENT, NO. FUNCTIONAL TESTS & RESULTS: CARTRIDGE LOCKOUT FUNCTIONAL, YES; CARTRIDGE REAR CAP PRESENT, YES; CLOSURE STROKE FUNCTIONAL, YES; FIRING TRIGGER LOCKOUT FUNCTIONAL, YES; INSTRUMENT CYCLED, YES; PROPER CARTRIDGE GUIDE, YES; RELEASE BUTTON CONDITION, GOOD; STAPLES FIRE PROPERLY, YES; STAPLES FORM PROPERLY, YES; TERST CARTRIDGE BATCH NUMBER, K46N1M AND TRIGGER RELEASE CONDITION, GOOD. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION AND THE FUNCTIONAL TEST, IT WAS CONCLUDED THAT THE INSTRUMENT WAS CONFORMING WITH REGARD TO STAPLES FIRING AND FORMING. THE INSTRUMENT WAS EXAMINED AND WAS FOUND TO BE FUNCTIONAL. A RELOADALBE TEST CARTRIDGE WAS INSERTED AND THE INSTRUMENT WAS CYCLCED, FIRED AND FORMED ALL STAPLES PROPERLY AND WITHOUT INCIDENT. ADDITIONALLY, THE BATCH HISTORY RECORDS WERE INVESTIGATED AND THERE WERE NO ANOMOLIES NOTED FOR MISSING STAPLES. IT COULD NOT BE ASCERTAINED AS TO WHY THERE WERE REPORTEDLY NO STAPLES IN THE CENTER OF THE STAPLE LINE. 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 THE PRODUCTS.

    Description of Event or Problem · 1

    DURING A THORACOTOMY, WEDGE RESECTION PROCEDURE, IT WAS REPORTED THE TX30B WAS FIRED ACROSS LUNG TISSUE AND WHEN THE JAWS WERE OPENED, THERE WERE STAPLES AT THE PROXIMAL DISTAL ENDS OF THE STAPLE LINE, BUT NONE IN THE CENTER. THE PROCEDURE WAS COMPLETED WITHOUT DIFFICULTY USING ANOTHER TX30B. 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 K45W2E

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other