BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLOS

    MDR report key: 107018 · Received March 13, 1997

    Report

    Report Number
    107018
    Event Type
    Malfunction
    Date Received
    March 13, 1997
    Date of Event
    March 3, 1997
    Report Date
    March 4, 1997
    Manufacturer
    BIRTCHER MEDICAL SYSTEMS INC. ENDOSCOPY DIVISION
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC CHOLECYSTECTOMY TIP OF 5MM RIGHT ANGLE CAUTERY PROBE BROKE. APPROX. 1/4" TIP LEFT IN PT. UNABLE TO RETRIEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLOS 5MM RIGHT ANGLE CAUTERY PROBE KNS BIRTCHER MEDICAL SYSTEMS INC. ENDOSCOPY DIVISION DC 289 *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other