BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUSTRIGHT 5MM STAPLER

    MDR report key: 11968723 · Received June 9, 2021

    Report

    Report Number
    3010377594-2021-00004
    Event Type
    Malfunction
    Date Received
    June 9, 2021
    Date of Event
    April 12, 2021
    Report Date
    July 12, 2021
    Manufacturer
    BOLDER SURGICAL
    Product Code
    GAG
    PMA / PMN Number
    K132472
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AN ADDITIONAL FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) FOR LOT 75JJ0520 WAS REVIEWED. NO ANOMALIES WERE NOTED ON THE LOT RELEASE PAPERWORK. INVESTIGATION OF RETURNED UNITS CONCLUDED THAT CLAMPING ON TISSUE OUTSIDE THE RANGE INDICATED IN THE INSTRUCTIONS FOR USE DEFORMED THE DEVICE, RESULTING IN THE REPORTED UNDER FORMED STAPLES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE THE STAPLER WAS FIRED ACROSS THE BRONCHUS AND IT WAS NOTICED THAT A FEW STAPLES WERE SECURED WHILE OTHERS WERE FREE FLOATING. THE STAPLER WAS FIRED A SECOND TIME AND THE SAME ISSUE OCCURRED. THE STAPLER CUT THROUGH THE BRONCHUS AND CAUSED AN AIR LEAK. THE PROCEDURE WAS COMPLETED BY SUTURING THE BRONCHUS AFTER THE UPPER LEFT LOBE OF THE LUNG WAS REMOVED. THERE WAS NO FURTHER PATIENT OR PROCEDURAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE THE STAPLER WAS FIRED ACROSS THE BRONCHUS AND IT WAS NOTICED THAT A FEW STAPLES WERE SECURED WHILE OTHERS WERE FREE FLOATING. THE STAPLER WAS FIRED A SECOND TIME AND THE SAME ISSUE OCCURRED. THE STAPLER CUT THROUGH THE BRONCHUS AND CAUSED AN AIR LEAK. THE PROCEDURE WAS COMPLETED BY SUTURING THE BRONCHUS AFTER THE UPPER LEFT LOBE OF THE LUNG WAS REMOVED. THERE WAS NO FURTHER PATIENT OR PROCEDURAL INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    THE CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THE STAPLER WAS FIRED ACROSS THE BRONCHUS AND IT WAS NOTICED THAT A FEW STAPLES WERE SECURED WHILE OTHERS WERE FREE FLOATING. THE STAPLER WAS FIRED A SECOND TIME AND THE SAME ISSUE OCCURRED. THE STAPLER CUT THROUGH THE BRONCHUS AND CAUSED AN AIR LEAK. THE PROCEDURE WAS COMPLETED BY SUTURING THE BRONCHUS AFTER THE UPPER LEFT LOBE OF THE LUNG WAS REMOVED. THERE WAS NO FURTHER PATIENT OR PROCEDURAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864595 JUSTRIGHT 5MM STAPLER SURGICAL STAPLER GAG BOLDER SURGICAL JR-ST25-2.0-6 75JJ0520

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO