BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEM FIXED-TIP ELECTRODE, 5MM-REUSABLE, J-HOOK

    MDR report key: 296131 · Received September 11, 2000

    Report

    Report Number
    1722040-2000-00006
    Event Type
    Malfunction
    Date Received
    September 11, 2000
    Date of Event
    August 21, 2000
    Report Date
    September 11, 2000
    Manufacturer
    ENCISION, INC.
    Product Code
    GEI
    Removal / Correction Number
    1722040-9/11/2000-01
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HOSPITAL REPORTED J-HOOK TIP BROKE OFF DURING "ELC" PROCEUDRE. TIP WAS RETRIEVED LAPAROSCOPICALLY. NO INJURY TO PT WAS REPORTED. REFERENCE ENCISION COMPLAINT #803. HOSP PROVIDED THE DEVICE FOR INSPECTION AND EVALUAITON BY MFR BUT REQUEST RETURN OF DEVICE ON COMPLETION OF INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEM FIXED-TIP ELECTRODE, 5MM-REUSABLE, J-HOOK LAPAROSCOPIC ELECTROSURGICAL DEVICE GEI ENCISION, INC. ES3510B EL

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other