BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JustRight 5mm Stapler

    MDR report key: 13341836 · Received January 25, 2022

    Report

    Report Number
    13341836
    Event Type
    Malfunction
    Date Received
    January 25, 2022
    Date of Event
    November 29, 2021
    Report Date
    January 12, 2022
    Manufacturer
    BOLDER SURGICAL, LLC
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING THE OPERATIVE PROCEDURE, WHILE USING THE PRODUCT, A PIECE OF THE HANDLE TO THE STAPLER BROKE IN THE SURGEON'S HAND. NO HARM OCCURRED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1223750 JustRight 5mm Stapler STAPLER, SURGICAL GAG BOLDER SURGICAL, LLC JR-ST25-2.0 75GA4605

    Patients

    Seq Age Sex Outcome Treatment
    1 210 DA Female Other