BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICAL LASER TECHNOLOGIES

    MDR report key: 16127 · Received July 21, 1994

    Report

    Report Number
    16127
    Event Type
    Malfunction
    Date Received
    July 21, 1994
    Date of Event
    May 19, 1994
    Report Date
    May 24, 1994
    Manufacturer
    SURGICAL LASER TECHNOLOIES, INCORPORATED
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC LASER SURGERY (VAPORIZING ENDOMETRIOSIS), THE SAPPHIRE LASER TIP WAS NOTED TO BE MISSING FROM METAL RETAINING COLLAR. TIP COULD NOT BE LOCATED WITHIN PATIENT. NO HARM NOTED TO PATIENT. PATIENT INFORMED OF EVENT BY SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL LASER TECHNOLOGIES CONTACT LASER PROBE SURGICAL LASER TECHNOLOIES, INCORPORATED N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 28 * Other