BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUSTRIGHT 5MM STAPLER

    MDR report key: 7181204 · Received January 10, 2018

    Report

    Report Number
    3010377594-2017-00003
    Event Type
    Malfunction
    Date Received
    January 10, 2018
    Date of Event
    December 7, 2017
    Report Date
    January 10, 2018
    Manufacturer
    JUSTRIGHT SURGICAL LLC
    Product Code
    GDW
    UDI-DI
    10865163000109
    PMA / PMN Number
    K132472
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: TWO RELOADS WERE RETURNED FROM THE PROCEDURE AND IT WAS NOT INDICATED WHICH HAD CAUSED THE REPORTED EVENT. BOTH RELOADS SHOWED EVIDENCE OF STAPLE TRACES IN THE ANVIL POCKETS. IT WAS NOTED THAT THE ANVIL HAD DEFLECTED SLIGHTLY IN ONE OF THE RELOADS INDICATING THICK TISSUE COULD BE A ROOT CAUSE. SUBSEQUENT CONVERSATION WITH THE SURGEON CONFIRMED THAT THE TIPS OF THE DEVICE WERE NOT VISIBLE DURING FIRING AND COMPLETE CLOSURE COULD NOT BE VERIFIED. BECAUSE THE APPENDIX WAS RETROCECAL, THE DOCTOR STATED SHE MAY HAVE USED THE DEVICE AS A RETRACTOR ON THE CECUM, CAUSING MISALIGNMENT BETWEEN THE STAPLES AND THE ANVIL, AND CONTRIBUTING TO IMPROPER STAPLE FORMATION. THE ROOT CAUSE IS LIKELY THAT THE CECUM WAS INADVERTENTLY CLAMPED AT THE DISTAL END OF THE RELOAD, PREVENTING STAPLES FROM FORMING PROPERLY. THE DEVICE HISTORY RECORDS (DHR) FOR LOT 75LF2007 WERE REVIEWED. THERE WERE NO ANOMALIES FOUND WITHIN THE DHR. THE LOT FOR THE SECOND RELOAD IS NOT KNOWN. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY AMENDED AS APPROPRIATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: DURING AN APPENDECTOMY, THE STAPLER APPEARED NORMAL AND SEEMED TO FIRE NORMALLY. WHEN THE SURGEON INSPECTED THE SPECIMEN (APPENDIX) THE SURGEON NOTICED THAT IT WAS OPEN AND CHECKED THE CECUM. UPON INSPECTION, THE CECUM WAS ALSO OPEN. THE OPENING IN THE CECUM WAS THEN STAPLED WITH A LARGER STAPLER. PATIENT IS "FINE" AND "DOING WELL." INCOMPLETE PATIENT INFORMATION (NAME, GENDER, BIRTH DATE, ETHNICITY, AND RACE WAS AVAILIABLE. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24390 JUSTRIGHT 5MM STAPLER JUSTRIGHT 5MM STAPLER GDW JUSTRIGHT SURGICAL LLC JR-ST25-2.0-6 75LF2007 10865163000109

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention