BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUSTRIGHT 5MM STAPLER

    MDR report key: 11978422 · Received June 10, 2021

    Report

    Report Number
    3010377594-2021-00006
    Event Type
    Injury
    Date Received
    June 10, 2021
    Date of Event
    May 6, 2021
    Report Date
    June 10, 2021
    Manufacturer
    BOLDER SURGICAL
    Product Code
    GAG
    PMA / PMN Number
    K132472
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR LOT 75AA0406 WAS REVIEWED. NO ANOMALIES WERE NOTED ON THE LOT RELEASE PAPERWORK. THE DEVICE WAS NOT RETURNED, WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POSTOPERATIVE BLEEDING OCCURRED AFTER THE PATIENT'S ZENKER'S DIVERTICULUM PROCEDURE. A REVISION SURGERY WAS PERFORMED AND THE BLEEDING WAS RESOLVED WITH AN ENDO STICH DEVICE. THE PATIENT IS REPORTED TO BE DOING WELL POSTOPERATIVELY. NO FURTHER SURGICAL OR PROCEDURE INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870335 JUSTRIGHT 5MM STAPLER SURGICAL STAPLER GAG BOLDER SURGICAL JR-ST25-2.0 75AA0406

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R