BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUSTRIGHT 5MM STAPLER

    MDR report key: 14626384 · Received June 7, 2022

    Report

    Report Number
    3010377594-2022-00011
    Event Type
    Injury
    Date Received
    June 7, 2022
    Date of Event
    April 22, 2022
    Report Date
    June 7, 2022
    Manufacturer
    BOLDER SURGICAL
    Product Code
    GAG
    PMA / PMN Number
    K132472
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE INVOLVED IN THIS EVENT WAS NOT RETURNED FOR EVALUATION PURPOSES THEREFORE VISUAL AND FUNCTIONAL ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED. WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE DEVICE AND THE ISSUE REPORTED AND A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE INFORMATION OBTAINED DURING COMPLAINT INVESTIGATION WILL BE INCLUDED IN OUR GLOBAL COMPLAINT TRENDING AND PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS TYPE FOR ADVERSE TRENDS. IF THE PRODUCT IS RECEIVED OR ADDITIONAL INFORMATION IS OBTAINED, THE INVESTIGATION WILL BE REOPENED ACCORDINGLY PER STANDARD OPERATING PROCEDURE. LOT AND SERIAL NUMBER OF THE DEVICE PROVIDED BY THE COMPLAINANT ARE INCOMPLETE; THEREFORE, THE UDI, EXPIRATION AND MANUFACTURING DATES ARE NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2022, DURING A GASTROSTOMY, THE JUSTRIGHT STAPLER MISFIRED WHILE TAKING DOWN THE EXISTING GASTROSTOMY. THIS INVOLVED CONVERTING TO OPEN GASTROSTOMY. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1320479 JUSTRIGHT 5MM STAPLER STAPLER, SURGICAL GAG BOLDER SURGICAL JR-ST25-2.0

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention