BEUDAMED
    FDA Adverse Event Other Summary report: N

    WOLF

    MDR report key: 87321 · Received April 25, 1997

    Report

    Report Number
    87321
    Event Type
    Other
    Date Received
    April 25, 1997
    Date of Event
    April 24, 1997
    Report Date
    April 24, 1997
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Product Code
    KNF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT SCHEDULED FOR LAPAROSCOPIC TUBAL STERILIZATION. DURING FIRST PROCEDURE, SURGEON ATTEMPTED TO CUT TISSUE WITH LAPAROSCOPY SCISSORS AND SCISSORS WOULD NOT CUT. SURGEON COULD NOT GET SCISSORS TO CLOSE, HAD TO REMOVE SCOPE WITH SCISSORS IN IT STILL IN OPEN POSITION. INCISION CLOSED AFTER PROCEDURE COMPLETED. PT TO PACU. UMBILICAL INCISION BEGAN TO OOZE BLOOD APPROX 20-30 MINUTES INTO RECOVERY. PRESSURE PLACED OVER INCISION FOR 20 MINUTES. APPROX 40 4X4'S COMPLETELY SOAKED. SURGEON SUMMONED. PT BROUGHT TO OR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WOLF SCISSORS/LAPAROSCOPY HOOK KNF RICHARD WOLF MEDICAL INSTRUMENTS CORP. 8384.02 *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other