BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARC ENDOCUFF

    MDR report key: 4770039 · Received May 13, 2015

    Report

    Report Number
    1651395-2015-00007
    Event Type
    Malfunction
    Date Received
    May 13, 2015
    Date of Event
    April 16, 2015
    Report Date
    May 13, 2015
    Manufacturer
    BODDINGTONS PLASTICS LTD
    Product Code
    FED
    PMA / PMN Number
    K122565
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDIVATORS RECEIVED FDA 3500A MEDWATCH FORM REPORT # (B)(4)STATING THAT AN ARC ENDOCUFF DETACHED FROM A COLONOSCOPE DURING A PROCEDURE. THE REPORT STATED THAT THE ENDOCUFF SLID OFF THE SCOPE TIP DURING SCOPE WITHDRAWAL. THE ENDOCUFF WAS REMOVED FROM THE PATIENT USING A ROTH RETRIEVAL NET. THE REPORT STATED THAT THERE WAS NO HARM TO THE PATIENT. PATIENT CONDITION UNKNOWN AT THIS TIME. THIS COMPLAINT WILL CONTINUE TO BE MONITORED THROUGH THE MEDIVATORS COMPLAINT HANDLING SYSTEM.

    Description of Event or Problem · 1

    MEDIVATORS RECEIVED FDA 3500A MEDWATCH FORM REPORT # (B)(4) STATING THAT AN ARC ENDOCUFF DETACHED FROM A COLONOSCOPE DURING A PROCEDURE. THE ENDOCUFF WAS REMOVED FROM THE PATIENT WITHOUT HARM.

    Description of Event or Problem · 1

    MEDIVATORS RECEIVED FDA 3500A MEDWATCH FORM REPORT # (B)(4) STATING THAT AN ARC ENDOCUFF DETACHED FROM A COLONOSCOPE DURING A PROCEDURE. THE REPORT STATED THAT THE ENDOCUFF SLID OFF THE SCOPE TIP DURING SCOPE WITHDRAWAL. THE ENDOCUFF WAS REMOVED FROM THE PATIENT USING A ROTH RETRIEVAL NET. THE REPORT STATED THERE WAS NO HARM TO THE PATIENT. PATIENT CONDITION UNKNOWN AT THE TIME. THIS COMPLAINT WILL CONTINUE TO BE MONITORED THROUGH THE MEDIVATORS COMPLAINT HANDLING SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313924 ARC ENDOCUFF ENDOSCOPIC ACCESS OVERTUBE FED BODDINGTONS PLASTICS LTD AEC120 045246

    Patients

    Seq Age Sex Outcome Treatment
    1 68.0 YR