BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARC ENDOCUFF

    MDR report key: 4736309 · Received April 29, 2015

    Report

    Report Number
    1651395-2015-00006
    Event Type
    Injury
    Date Received
    April 29, 2015
    Date of Event
    January 26, 2015
    Report Date
    April 29, 2015
    Manufacturer
    BODDINGTONS PLASTICS LTD
    Product Code
    FED
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CASE STATES THAT AN ARC ENDOCUFF AEC140 CAME OFF MID PROCEDURE. NEW INFORMATION WAS RECEIVED YESTERDAY FROM THE MEDIVATORS SALES REPRESENTATIVE THAT THE ENDOCUFF DETACHED FROM THE DISTAL END OF THE SCOPE WHILE THE PHYSICIAN WAS PERFORMING A COLONOSCOPY PROCEDURE. THIS ADDITIONAL CASE INFORMATION ESCALATED THE COMPLAINT TO US MDR REPORTABILITY STATUS. THE COLONOSCOPY PROCEDURE WAS PROLONGED 20-30 MINUTES BECAUSE THERE WAS DIFFICULTY REMOVING THE DEVICE. THE PATIENT WAS SEDATED AND IT WAS REPORTED THAT THE PHYSICIAN STARTED THE PROCEDURE OVER ONCE THE DEVICE WAS REMOVED. THE PHYSICIAN DID NOT REPORT ANY PATIENT INJURY OR CONCERN FOR POTENTIAL HARM TO THE PATIENT. THERE IS LIMITED INFORMATION REGARDING CURRENT PATIENT STATUS. THERE WAS NO REPORTED INFORMATION OF PATIENT ILLNESS OR INJURY AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283458 ARC ENDOCUFF ENDOSCOPIC ACCESS OVERTUBE FED BODDINGTONS PLASTICS LTD AEC 140

    Patients

    Seq Age Sex Outcome Treatment
    1