BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH THORACIC ENDO LINEAR CUTTER RELOAD

    MDR report key: 138327 · Received December 15, 1997

    Report

    Report Number
    1527736-1997-03416
    Event Type
    Injury
    Date Received
    December 15, 1997
    Date of Event
    September 9, 1997
    Manufacturer
    ETHICON ENDO SURGERY INC
    Product Code
    GAG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    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 ADHEXA. BILATERALLY, SOME PEDICLES APPEARED TO NOT HAVE STAPLES AFTER FIRING AND THE SURGEON COMPLETED THE CASE BY HAND SEWING THE PEDICLES. THERE WERE APPROX. 1100CC OF BLOOD LOSS THAT OCCURRED AND THE PT 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. 9/30/97 RECEIVED USER FACILITY MEDWATCH REPORT #190124-1997-00001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH THORACIC ENDO LINEAR CUTTER RELOAD THORACIC ENDOSCOPIC LINEAR CUT GAG ETHICON ENDO SURGERY INC NA K46X9N

    Patients

    Seq Age Sex Outcome Treatment
    1 Other