BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALLEYLAB ELECTROSURGICAL GENERATOR

    MDR report key: 178844 · Received July 24, 1998

    Report

    Report Number
    1717344-1998-00056
    Event Type
    Malfunction
    Date Received
    July 24, 1998
    Date of Event
    July 11, 1996
    Report Date
    July 23, 1998
    Manufacturer
    VALLEYLAB, INC.
    Product Code
    GEI
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    LEGAL NOTIFICATION REC'D INDICATED THAT THE PT UNDERWENT TUBAL LIGATION AND WITHIN MINUTES OF COMMENCING THE LAPAROSCOPIC SURGERY. THE DR PERFORATED THE PT'S BROAD LIGAMENT AND SEVERED HER ILIAC VEIN. IMMEDIATE REPAIR OF VENOUS INJURY WAS REQUIRED TO STOP HEMORRHAGING. ON JULY 12, 1996 THE PT WAS TAKEN TO EMERGENCY SURGERY TO REMOVE A METALLIC GUIDE WIRE WHICH HAD BEEN LEFT IN THE PT FOLLOWING SURGERY. ON JULY 14, 1996 THE PT WAS TAKEN BACK TO SURGERY TO REPAIR A PERFORATED COLON. ON JULY 22, 1996 THE PT WAS DIAGNOSED WITH PLEURAL EFFUSION REQUIRING THORACENTESIS, WHICH WAS PERFORMED AT BEDSIDE. THEN ON JULY 27, 1996 THE PT REQUIRED ULTRASOUND-GUIDED DRAINAGE OF INFECTED LUNG. THE PT SUSTAINED PERMANENT VENOUS, ORGAN AND COLONIC INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALLEYLAB ELECTROSURGICAL GENERATOR ELECTROSURGICAL GENERATOR GEI VALLEYLAB, INC. SSE2K-11 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR