BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL DISTAL ATTACHMENT CAP

    MDR report key: 5085093 · Received September 17, 2015

    Report

    Report Number
    1528319-2015-00024
    Event Type
    Injury
    Date Received
    September 17, 2015
    Date of Event
    August 18, 2015
    Report Date
    September 15, 2015
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Product Code
    OCX
    PMA / PMN Number
    K140315
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVEAL DISTAL ATTACHMENT CAP HAS BEEN DESIGNED TO BE ATTACHED TO THE DISTAL END OF THE ENDOSCOPE TO FACILITATE ENDOSCOPIC THERAPY. THE REVEAL DISTAL ATTACHMENT CAP IS INTENDED FOR GASTROINTESTINAL MUCOSAL RESECTION (ENDOSCOPIC MUCOSAL RESECTION) AND FOR KEEPING THE SUITABLE DEPTH OF ENDOSCOPE'S VIEW FIELD. THE USER REPORTED THE REVEAL DISTAL ATTACHMENT CAP BECAME DETACHED FROM THE ENDOSCOPE DURING A PROCEDURE IN THE DUODENUM. THE REVEAL DISTAL ATTACHMENT CAP WAS IMMEDIATELY REMOVED WITH A RETRIEVAL DEVICE, WITH NO HARM TO THE PATIENT AS A RESULT OF THE DEVICE DETACHMENT OR DEVICE REMOVAL. IN FOLLOW UP COMMUNICATION, US ENDOSCOPY LEARNED THE USER DID NOT SECURE THE DEVICE TO THE ENDOSCOPE WITH MEDICAL GRADE TAPE, AS DIRECTED IN THE INSTRUCTIONS FOR USE (IFU). ADDITIONAL INFORMATION FOUND IN THE IFU DIRECTS THE USER TO VERIFY THE OUTER DIAMETER OF THE ENDOSCOPE IS COMPATIBLE WITH THE INNER DIAMETER OF THE DEVICE, AND DIRECTS THE USER TO ENSURE THE DEVICE AND THE TIP OF THE ENDOSCOPE ARE DRY AND FREE OF LUBRICANTS, OILS, ALCOHOL, OR XYLOCAINE SPRAY, PRIOR TO ATTACHMENT OF THE DEVICE. THE USER HAS BEEN INFORMED OF THE ATTACHMENT DIRECTIONS FOUND IN THE INSTRUCTIONS FOR USE. A REVIEW OF THE MANUFACTURING RECORD FOUND NO ANOMALIES NOTED DURING MANUFACTURE AND FOUND TESTS AND INSPECTIONS WERE PERFORMED WITH ACCEPTABLE RESULTS DOCUMENTED. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE REVEAL DISTAL ATTACHMENT CAP HAS BEEN DESIGNED TO BE ATTACHED TO THE DISTAL END OF THE ENDOSCOPE TO FACILITATE ENDOSCOPIC THERAPY. THE REVEAL DISTAL ATTACHMENT CAP IS INTENDED FOR GASTROINTESTINAL MUCOSAL RESECTION (ENDOSCOPIC MUCOSAL RESECTION) AND FOR KEEPING THE SUITABLE DEPTH OF ENDOSCOPE'S VIEW FIELD. THE USER REPORTED THE REVEAL DISTAL ATTACHMENT CAP BECAME DETACHED FROM THE ENDOSCOPE DURING A PROCEDURE IN THE DUODENUM. THE REVEAL DISTAL ATTACHMENT CAP WAS IMMEDIATELY REMOVED WITH A RETRIEVAL DEVICE, WITH NO HARM TO THE PATIENT AS A RESULT OF THE DEVICE DETACHMENT OR DEVICE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615455 REVEAL DISTAL ATTACHMENT CAP DISTAL ATTACHMENT CAP OCX UNITED STATES ENDOSCOPY GROUP, INC. 00711772 1503800

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention