BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUSTRIGHT 5MM STAPLER

    MDR report key: 11558240 · Received March 23, 2021

    Report

    Report Number
    3010377594-2021-00001
    Event Type
    Injury
    Date Received
    March 23, 2021
    Date of Event
    January 14, 2021
    Report Date
    March 23, 2021
    Manufacturer
    BOLDER SURGICAL
    Product Code
    GAG
    UDI-DI
    10865163000109
    PMA / PMN Number
    K132472
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) FOR LOT 75IJ1734 WAS REVIEWED. NO ANOMALIES WERE NOTED ON THE LOT RELEASE PAPERWORK. NO ROOT CAUSE FOR THIS MALFUNCTION COULD BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    SURGEON USED STAPLER AS INTENDED IN LAP APPENDECTOMY, BUT STAPLE LINE HAD BLEEDING, CONCERNING FOR INCOMPLETE OCCLUSION. SURGEON CAUTERIZED BLEED AND TOOK ADDITIONAL STEPS TO SECURE STAPLER LINE. SHE FIRED A 5MM ADULT MEDTRONIC STAPLER (GOLD TRISTAPLE RELOAD) BELOW THE INITIAL BOLDER SURGICAL STAPLE LINE. WHEN THE SECOND STAPLE LINE WAS FIRED, IT PUSHED TISSUE THROUGH THE STAPLE LINE. SHE THEN SECURED THE STAPLE LINE WITH AN ENDOLOOP AND SENT THE APPENDIX TO PATHOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450245 JUSTRIGHT 5MM STAPLER SURGICAL STAPLER GAG BOLDER SURGICAL JR-ST25-2.0-6 75IJ1734 10865163000109

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention