BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUSTRIGHT 5MM STAPLER

    MDR report key: 8154483 · Received December 12, 2018

    Report

    Report Number
    8154483
    Event Type
    Injury
    Date Received
    December 12, 2018
    Date of Event
    December 3, 2018
    Report Date
    December 11, 2018
    Manufacturer
    JUSTRIGHT SURGICAL, LLC
    Product Code
    GAG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    YOUNG CHILD PATIENT UNDERWENT APPENDECTOMY USING THE STAPLER. BY SURGEON REPORT AFTER THE EVENT, THE OPERATION WAS PERFORMED WITHOUT DIFFICULTY OR COMPLICATIONS. THE PATIENT WAS DISCHARGED HOME, BUT BROUGHT BACK SEVERAL DAYS LATER WITH ACUTE ABDOMINAL PAIN. A CT SCAN DEMONSTRATED BOWEL INVOLVEMENT AT THE SURGICAL SITE, AND THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR EXPLORATION. THE SURGEON DISCOVERED THAT A STAPLE USED PREVIOUSLY HAD BENT AND MIGRATED IN SUCH A WAY AS TO CAUSE INFLAMMATION AND OBSTRUCTION. THE STAPLE WAS REMOVED, AND THE BOWEL REPAIRED WITH NO FURTHER COMPLICATIONS. A RESECTION WAS NOT REQUIRED, AND THE CHILD SUBSEQUENTLY IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    996519 JUSTRIGHT 5MM STAPLER STAPLER, SURGICAL GAG JUSTRIGHT SURGICAL, LLC JR-ST25-2.0

    Patients

    Seq Age Sex Outcome Treatment
    1 1825 DA Hospitalization| O| R