BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUST RIGHT 5MM STAPLER

    MDR report key: 14488337 · Received May 23, 2022

    Report

    Report Number
    MW5109851
    Event Type
    Injury
    Date Received
    May 23, 2022
    Date of Event
    February 16, 2021
    Report Date
    May 19, 2022
    Manufacturer
    BOLDER SURGICAL, LLC
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AFTER A THORASCOPIC RESECTION OF A SEQUESTRATION, IT WAS NOTED UPON TRYING TO WAKE THE PATIENT UP THAT THERE WAS A FAIR AMOUNT OF BLOOD ON THE CHEST TUBE DRESSING SITE. THE RESIDENT AND PA WERE NOTIFIED, AND THEY REACHED OUT TO THE SURGEON. BY THE TIME THE SURGEON WAS COMING BACK TO THE OPERATING ROOM SUITE, IT WAS NOTED THAT BLOOD WAS OOZING AROUND THE DRESSING SITE AND THAT A COPIOUS AMOUNT OF BLOOD WAS NOW IN THE TUBING OF THE PLEUR-EVAC. THE SURGEON REQUESTED WE SET BACK UP SO HE COULD GO IN AND LOOK TO SEE IF HE COULD FIND THE SOURCE OF ALL THE BLOOD. A THORASCOPIC SET-UP WAS THEN USED TO EVALUATE THE PATIENT. NOTHING SIGNIFICANT WAS FOUND AND THEREFORE THE SURGEON CLOSED THE WOUND SITES. SHORTLY AFTER FINISHING THAT, IT WAS NOTED THAT BLOOD WAS STILL COMING OUT OF THE CHEST TUBE SITE AND THEREFORE THE SURGEON DECIDED TO DO AN OPEN THORACOTOMY TO TRY TO FIND THE SOURCE OF THE BLEEDING. WHILE PERFORMING THE THORACOTOMY, THE SURGEON NOTED THAT THERE WAS BLEEDING AROUND THE STAPLE LINE. THE SURGEON PROCEEDED TO CAUTERIZE AND OVER SEW WITH SUTURE TO STOP THE BLEEDING. THE SURGEON USED THE JUST RIGHT STAPLER. REF. # JR-ST25-2.0, LOT: 75IA7102, EXP. 10/07/2023. BABY WAS THEN TRANSPORTED TO PICU. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150524 JUST RIGHT 5MM STAPLER STAPLER, SURGICAL GAG BOLDER SURGICAL, LLC REF. # JR-ST25-2.0 75IA7102

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO Male Required Intervention