BEUDAMED
    FDA Adverse Event Other Summary report: N

    SNOWDEN-PENCER INSTRUMENT

    MDR report key: 191518 · Received October 9, 1998

    Report

    Report Number
    MW1014721
    Event Type
    Other
    Date Received
    October 9, 1998
    Date of Event
    October 2, 1998
    Report Date
    October 9, 1998
    Manufacturer
    GENZYME SURGICAL PRODUCTS CORP.
    Product Code
    KNF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE DOING LAPAROSCOPIC SURGERY, FULGERATING WITH A SNOWDEN-PENCER INSTRUMENT, BURN OCCURRED ON UTERUS. UPON EXAMINATION OF DISPOSABLE SCISSOR TIP, INSULATOR WAS FOUND TO BE FAULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SNOWDEN-PENCER INSTRUMENT DISPOSABLE SCISSOR TIP KNF GENZYME SURGICAL PRODUCTS CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other