BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURE-VU SYSTEM

    MDR report key: 7678091 · Received July 11, 2018

    Report

    Report Number
    3011816755-2018-00002
    Event Type
    Injury
    Date Received
    July 11, 2018
    Date of Event
    June 20, 2018
    Report Date
    July 9, 2018
    Manufacturer
    MOTUS GI MEDICAL TECHNOLOGIES LTD.
    Product Code
    FDF
    UDI-DI
    05060513700052
    PMA / PMN Number
    K181437
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED WITHIN A CLINICAL STUDY (IRB ID #: (B)(4)) AS AN ANTICIPATED EVENT. AFTER ANESTHESIA WORE OFF, PATIENT COMPLAINED OF ABDOMINAL PAIN. X-RAYS SHOWED FREE AIR; AN EXPLORATORY LAPAROSCOPY WAS PERFORMED ALONG WITH REPAIR OF PERFORATION. A 1 CM INJURY WAS FOUND AT THE RECTOSIGMOID JUNCTION OF THE COLON AND THIS WAS REPAIRED WITH SUTURING. THE PATIENT TOLERATED THE PROCEDURE WELL AND DISCHARGED 2 DAYS AFTER THE OPERATION WITH NO FURTHER COMPLICATIONS. THE EVENT MAY BE RELATED TO THE RETROFLEX ATTEMPTS THAT PHYSICIAN MADE DURING THE PROCEDURE. PERFORATIONS ARE AN ANTICIPATED RISK DURING COLONOSCOPY WHERE RETROFLEX IS KNOWN TO ELEVATE SUCH RISKS PARTICULARLY IN A NARROW ANATOMY; ISSUE WILL CONTINUE TO BE TRENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520551 PURE-VU SYSTEM COLONOSCOPE AND ACCESSORIES FDF MOTUS GI MEDICAL TECHNOLOGIES LTD. PV-OS-001 402454 05060513700052

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention COLONOSCOPE