BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS

    MDR report key: 137664 · Received December 11, 1997

    Report

    Report Number
    1527736-1997-03381
    Event Type
    Malfunction
    Date Received
    December 11, 1997
    Date of Event
    November 12, 1997
    Report Date
    November 12, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURNED WITH NO LOT ID. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: ANY OTHER NOTICEABLE DAMAGE, NO; BATCH NUMBER, K00200; CARTRIDGE PAN IN PLACE/CONDITION, YES/GOOD; CONDITION OF DRIVERS, GOOD; LOCKOUT TABS ON PAN CONDITION, FIRED AND POSITION/CONDITION OF WEDGE SLEDS, FULLY FIRED. FUNCTIONAL TESTS & RESULTS: CONDITION OF CLAMP FIRST LOCKOUT, N/A; CONDITION OF CLAMPING MECHANISM, N/A; CONDITION OF FIRING MECHANISM, N/A; CONDITION OF KNIFE, N/A; CONDITION OF WEDGE BANDS, N/A; IS HYPER LOCKOUT CONDITION PRESENT, N/A AND RESULT OF ATTEMPTED FIRING, N/A. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO REC'D, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE CARTRIDGE REPORTEDLY PRODUCED "MALFORMED STAPLES" DURING SURGERY. THE CARTRIDGE WAS RETURNED FULLY FIRED AND IN GOOD PHYSICAL CONDITION. NO TESTING COULD BE PERFORMED AS THE CARTRIDGE HAD BEEN FULLY FIRED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A LAPAROSCOPIC OOPHORECTOMY THE SURGEON HAD FIRED THE DEVICE AND ONLY SOME STAPLES FORMED AND THE DEVICE DID NOT COMPLETELY CUT THE TISSUE. THERE WAS NO FURTHER INFO SURROUNDING THIS DEVICE. THE REP WAS CALLED INTO THE ROOM. A SECOND ETS WAS OPENED, THE SURGEON ATTEMPTED TO FIRE THE INSTRUMENT AND THE CARTRIDGE WOULD NOT FIRE. A NEW CARTRIDGE WAS PLACED ON THE ETS AND IT FIRED PROPERLY. THERE WAS NO PT CONSEQUENCE. 11/21/97 THE REP REPORTS THE FIRST ETS WAS NOT SAVED AND IT IS UNKNOWN IF IT WAS THE INITIAL OR THE SECOND FIRING OF IT. REP WAS PRESENT DURING THE FIRING OF THE SECOND ETS. THE INITIAL FIRING WAS FINE. ON THE SECOND RELOAD IT WOULD NOT FIRE. THE REP NOTED DRIVERS IN THE END OF THE CARTRIDGE. THE SAME DEVICE WAS RELOADED AND THE NEXT TWO FIRINGS WORKED PROPERLY. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS LINEAR CUTTER KOG ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other