BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLSEN

    MDR report key: 201536 · Received December 14, 1998

    Report

    Report Number
    201536
    Event Type
    Injury
    Date Received
    December 14, 1998
    Date of Event
    December 7, 1998
    Report Date
    December 14, 1998
    Manufacturer
    OLSEN ELECTROSURGICAL INSTRUMENTS, INC
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING OTOPLASTY BILATERAL EARS SURGICAL PROCEDURE, PHYSICIAN NOTICED A 0.5CM BURNED AREA AT SKIN EDGE WHILE USING AN ELECTROSURGICAL UNIT WITH A NEEDLE TIP. NEEDLE TIP WAS REMOVED FROM FIELD IMMEDIATELY. EXCISION SITE WAS EXTENDED A LITTLE MORE THAN INTENDED TO INCLUDED ADDITIONAL BURNED AREA CAUSED BY NEEDLE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLSEN ELECTROSURGICAL NEEDLE TIP ELECTRODE GEI OLSEN ELECTROSURGICAL INSTRUMENTS, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention