BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSS

    MDR report key: 15893720 · Received December 1, 2022

    Report

    Report Number
    3009051471-2020-00010
    Event Type
    Malfunction
    Date Received
    December 1, 2022
    Date of Event
    December 23, 2019
    Report Date
    November 14, 2022
    Manufacturer
    BOSS INSTRUMENTS LTD
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    GENERAL SURGICAL INSTRUMENT, MICRO-PITUITARY FROM BOSS INSTRUMENT, LTD, TIP BROKE AT DISTAL END. THIS INSTRUMENT IS SUPPLIED BUT NOT MANUFACTURED BY CTL. NO PATIENT HARM OR INJURY WAS OBSERVED. NO DETAILED INFORMATION PROVIDED. NO PART RETURNED. THIS WAS JUST A NOTIFICATION WITHOUT ANY FOLLOW-UP BY THE INFORMANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1742267 BOSS MICRO PITUITARY LXH BOSS INSTRUMENTS LTD 70-1470P

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown