BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORISE

    MDR report key: 7838696 · Received August 31, 2018

    Report

    Report Number
    3005099803-2018-60233
    Event Type
    Injury
    Date Received
    August 31, 2018
    Date of Event
    August 9, 2018
    Report Date
    August 31, 2018
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GAD
    UDI-DI
    08714729974604
    PMA / PMN Number
    K173400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS NOT KNOWN PER THE COMPLAINANT; THEREFORE, THE DEVICE MANUFACTURE AND EXPIRATION DATES CANNOT BE DETERMINED. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED OF AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORISE TISSUE RETRACTION SYSTEM WAS USED IN THE RECTAL/SIGMOID REGION OF THE COLON DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE DEVICE WAS BEING USED TO RESECT A 4 CM FLATTER LESION THAT TESTED POSITIVE FOR HIGH-GRADE DYSPLASIA (HGD) ON BIOPSY. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND PRIOR TO INSERTING THE ORISE DEVICE, A CIRCUMFERENTIAL MUCOSAL CUT WAS MADE AND APPROXIMATELY 30% OF THE LESION WAS DISSECTED USING TRADITIONAL ESD METHODS. THE ORISE DEVICE WAS THEN INSERTED TO VISUALIZE THE LESION AND WAS PUSHED THROUGH THE PORTION OF THE LESION THAT HAD BEEN DISSECTED, CAUSING A PERFORATION. REPORTEDLY, THE PHYSICIAN MAY HAVE "PUSHED TOO HARD" WHEN INSERTING THE DEVICE. THE PERFORATION WAS TREATED BY LAPAROSCOPICALLY PERFORMING A RECTAL SIGMOID RESECTION, REMOVING THE LESION AND THE PERFORATION, AND CONNECTING THE ANASTOMOSIS. THERE HAVE BEEN NO FURTHER PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680114 ORISE TISSUE RETRACTOR SYSTEM GAD BOSTON SCIENTIFIC CORPORATION M00519510 08714729974604

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention