BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUSTRIGHT 5MM STAPLER

    MDR report key: 13044205 · Received December 20, 2021

    Report

    Report Number
    3010377594-2021-00010
    Event Type
    Malfunction
    Date Received
    December 20, 2021
    Date of Event
    November 17, 2021
    Report Date
    November 20, 2021
    Manufacturer
    BOLDER SURGICAL
    Product Code
    GAG
    UDI-DI
    00865163000102
    PMA / PMN Number
    K132472
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR LOT 75DA2823 WAS REVIEWED. NO ANOMALIES WERE NOTED ON THE LOT RELEASE PAPERWORK. RELOAD DEVICE WAS RETURNED FOR INVESTIGATION, AND THE COMPLAINT WAS CONFIRMED. IT IS POSSIBLE THE STAPLER WAS FIRED ON TOO THICK OR TOUGH TISSUE, BUT THIS COULD NOT BE CONFIRMED. OBSERVATION OF THE KNIFE BLADE APPEARS TO INDICATE THE RELOAD WAS FIRED OVER ANOTHER STAPLE LINE, BUT THE SURGEON STATED THAT THIS WAS NOT THE CASE. 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 · 0

    IT WAS REPORTED THAT THE SURGEON IDENTIFIED MALFORMED STAPLES ON THE RIGHT SIDE OF THE CUT LINE NEAR THE DISTAL TIP OF THE STAPLE LINE. PATIENT INFORMATION WAS NOT PROVIDED. PATIENT IMPACT WAS ADDITIONAL SURGICAL INTERVENTION. THE PATIENT HAS NOW RECOVERED AND HAS BEEN DISCHARGED. THE DISPOSABLE STAPLER HANDLE WAS DISPOSED OF AN WAS NOT AVAILABLE FOR RETURN, BUT THE RELOAD USED DURING THE EVENT WAS RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1946055 JUSTRIGHT 5MM STAPLER SURGICAL STAPLER GAG BOLDER SURGICAL JR-ST25-2.0 75DA2823 00865163000102

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention