BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS FLEX

    MDR report key: 148363 · Received February 6, 1998

    Report

    Report Number
    1527736-1998-00275
    Event Type
    Malfunction
    Date Received
    February 6, 1998
    Date of Event
    January 8, 1998
    Report Date
    January 8, 1998
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    D5,6; H2,3,4,6; G4: ADDED ADDITIONAL INFO. H6; WEDGE BAND BYPASS. RESULTS OF INVESTIGATION CONDUCTED BY APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: BATCH NUMBER, A K01131 B K017; CARTRIDGE PAN IN PLACE/CONDITION, AB YES/GOOD; CONDITION OF DRIVERS, A ROLLED B GOOD; LOCKOUT TABS ON PAN CONDITION, AB FIRED AND POSITION/CONDITION OF WEDGE SLEDS, AB PARTIALLY FIRED. FUNCTIONAL TESTS & RESULTS: CONDITION OF CLAMP FIRST LOCKOUT, GOOD; CONDITION OF CLAMPING MECHANISM, GOOD; CONDITION OF FIRING MECHANISM, GOOD; CONDITION OF KNIFE, GOOD; CONDITION OF WEDGE BANDS, GOOD; IS HYPER LOCKOUT CONDITION PRESENT, NO AND RESULT OF ATTEMPTED FIRING, GOOD. ANALYSIS CONCLUSION: BASED UPON INFO RECEIVED AND VISUAL EXAMINATION, IT WAS CONCLUDED THAT CARTRIDGE A WAS RETURNED WITH WEDGE BAND BYPASS. NO CONCLUSION COULD BE REACHED AS TO WHAT CAUSED WEDGE BAND BYPASS. INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED STAPLES WITHIN DESIGN SPECIFICATION. INSTRUMENT WAS DISASSEMBLED TO EXAMINE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE IDENTIFIED. IT WAS CONCLUDED THAT INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. EACH INSTRUMENT IS EVALUATED DURING ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS USED DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY PROCEDURE. IT WAS REPORTED DURING THE SECOND OR THIRD FIRING OF THE ATW35, THE SURGEON NOTICED BLEEDING FROM THE SIDE OF THE CUT LINE. THE SURGEON USED CLIPS FROM AN ER320 TO ACHIEVE HEMOSTASIS. IT WAS REPORTED IT APPEARED NO STAPLES FORMED ON THE PT SIDE. THE SURGEON COMPLETED THE PROCEDURE WITH A SECOND ATW35. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS FLEX LINEAR CUTTER KOG ETHICON ENDO-SURGERY, INC. NA K48J3A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other