BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUSTRIGHT¿ STAPLER 5 MM

    MDR report key: 20306247 · Received September 25, 2024

    Report

    Report Number
    3010377594-2024-00011
    Event Type
    Injury
    Date Received
    September 25, 2024
    Date of Event
    January 1, 2024
    Report Date
    November 15, 2024
    Manufacturer
    BOLDER SURGICAL
    Product Code
    GAG
    UDI-DI
    100865163000109
    PMA / PMN Number
    K132472
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT/SERIAL NUMBER. THE DEVICE WAS RELEASED MEETING ALL QA SPECIFICATIONS. ADDITIONAL INFORMATION RECEIVED: THE PROCEDURE DATE IS (B)(6) 2024.

    Additional Manufacturer Narrative · 0

    LOT AND SERIAL NUMBER OF THE DEVICE NOT PROVIDED BY THE COMPLAINANT; THEREFORE, THE UDI, EXPIRATION AND MANUFACTURING DATES ARE NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICE AS THE IDENTIFICATION NUMBERS WERE NOT PROVIDED BY THE COMPLAINANT. 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. 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.

    Additional Manufacturer Narrative · 0

    PLEASE CORRECT THE MFR SITE ADDRESS IS 331 SOUTH 104 STREET.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024 A 9-YEAR-OLD A PATIENT RECEIVED AN APPENDECTOMY AND A REPAIR OF A SUPRAUMBILICAL HERNIA IN WHICH A JUST RIGHT STAPLER WAS USED. THE PROCEDURE WAS REPORTED AS SUCCESSFUL AND NO ISSUES DURING THE ORIGINAL PROCEDURE AND THE STAPLE LINE FORMED AND SEALED APPROPRIATELY. THE PHYSICIAN REPORTED THAT A WEEK LATER THE PATIENT DEVELOPED DENSE ADHESIONS AT THE STAPLE LINE WHICH REQUIRED INTERVENTION. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1198285 JUSTRIGHT¿ STAPLER 5 MM STAPLER, SURGICAL GAG BOLDER SURGICAL JR-ST25-2.0 75EC0704 100865163000109

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Unknown Other