BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOOD BOLUS ROTH NET

    MDR report key: 3140074 · Received May 29, 2013

    Report

    Report Number
    1528319-2013-00033
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 29, 2013
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED WAS NOT RETURNED FOR INVESTIGATION, THEREFORE, THE ROOT CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED. REVIEW OF THE LOT HISTORY RECORDS REVEALS NO PROBLEMS IN THE MANUFACTURING OF THIS DEVICE. ATTEMPTS HAVE BEEN MADE TO GATHER FURTHER DETAILS REGARDING THE INCIDENT, BUT THE COMPANY HAS NOT RECEIVED ANY ADDITIONAL INFO AT THIS TIME. THERE WAS NO REPORTED HARM OR INJURY TO ANY PT.

    Description of Event or Problem · 1

    THE DISPOSABLE ROTH NET RETRIEVAL DEVICE PRODUCT LINE IS USED IN THE ENDOSCOPIC RETRIEVAL OF FOREIGN BODY, FOOD BOLUS AND EXCISED TISSUE SUCH AS POLYPS. THE COMPANY RECEIVED A COMPLAINT THAT WHILE THE CUSTOMER WAS TRYING TO REMOVE A FOOD BOLUS, THE SNARE LOOP STARTED TWISTING OUT OF FORM. THE CUSTOMER WAS UNABLE TO REMOVE THE FOOD BOLUS. THE CUSTOMER THEN TRIED USING ANOTHER MANUFACTURER'S DEVICE TO REMOVE THE FOOD BOLUS, BUT THAT DEVICE DID NOT WORK EITHER. THE CUSTOMER WAS UNABLE TO COMPLETE THE PROCEDURE; HOWEVER, THERE WAS NO REPORTED HARM OR INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236578 FOOD BOLUS ROTH NET ROTH NET KOG UNITED STATES ENDOSCOPY GROUP, INC. 00711155 86320

    Patients

    Seq Age Sex Outcome Treatment
    1