BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAFETY LOCK

    MDR report key: 125592 · Received October 9, 1997

    Report

    Report Number
    1527736-1997-02581
    Event Type
    Injury
    Date Received
    October 9, 1997
    Date of Event
    September 10, 1997
    Report Date
    September 10, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Adverse Event
    Yes
    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: LOCKOUT POSITION, LOCKED OUT; CARTRIDGE CONDITION, FULLY FIRED AND CARTRIDGE RETURN BATCH NUMBER, K00W8T. FUNCTIONAL TESTS & RESULTS: CONDITION OF FIRING TRIGGER LOCKOUT, GOOD; CONDITION OF PINION GEAR, GOOD; CONDITION OF SHORT RACK, GOOD; CONDITION OF YOKE, GOOD; TEST CARTRIDGE BATCH # K01142 AND WAS INSTRUMENT CYCLED, NO. 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 INSTRUMENT REPORTEDLY "DID NOT HAVE STAPLES" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPEC. THE INSTRUMENT WAS DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE IDENTIFIED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A TOTAL VAGINAL HYSTERECTOMY THE EZ45B AND THE ZR45B WERE USED TO TAKE DOWN THE ADNEXA. BILATERALLY, SOME PEDICLES APPEARED TO NOT HAVE STAPLES AFTER FIRING AND THE SURGEON COMPLETED THE CASE BY HAND SEWING THE PEDICLES. THERE WAS APPROXIMATELY 1100CC OF BLOOD LOSS THAT OCCURRED AND THE PATIENT WAS GIVEN 1 UNIT OF PLASMA. THE SURGEON REPORTS THERE WAS NO ANATOMICAL ABNORMALITIES AND THE UTERUS WAS NORMAL IN SIZE. IT IS APPROXIMATED THAT OR TIME WAS EXTENDED BY OVER AN HOUR. NO OTHER POST OPERATIVE COMPLICATIONS HAVE BEEN REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAFETY LOCK ENDOSCOPIC LINEAR CUTTER GAG ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other