BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANOSCAN

    MDR report key: 7070165 · Received November 30, 2017

    Report

    Report Number
    3005344223-2017-05008
    Event Type
    Injury
    Date Received
    November 30, 2017
    Date of Event
    November 16, 2017
    Report Date
    January 31, 2018
    Manufacturer
    GIVEN IMAGING LOS ANGELES LLC
    Product Code
    FFX
    PMA / PMN Number
    K151086
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THIS REPORT WILL BE BASED ON INFORMATION PROVIDED BY THE TECH SUPPORT. THE RETURNED SAMPLE MET SPECIFICATION AS RECEIVED BY MANUFACTURER. THE CUSTOMER REPORTED THERE IS DISCOLORATION. THE INVESTIGATION FOUND THE CATHETER PASSED CALIBRATION. THE DISCOLORATION IS VISIBLE , BUT NOT ABNORMAL. THE UNIT WAS FULLY TESTED AND FOUND TO MEET OPERATIONAL SPECIFICATIONS AND FUNCTION NORMALLY. THIS UNIT DOES NOT MEET THE REQUIREMENTS FOR A MANUFACTURING OR SERVICE FAILURE THEREFORE. INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THEIR CATHETER IS SHOWING DISCOLORATION AND CORROSION. IT IS ALSO STATED THAT IT WAS DIFFICULT TO REMOVE DURING THE LAST PROCEDURE AND NEEDED ENT ASSISTANCE AFTER IT BECAME LODGED AGAINST A NASAL SEPTAL SPUR. THE DEVICE WILL BE RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849092 MANOSCAN SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) FFX GIVEN IMAGING LOS ANGELES LLC 3890-

    Patients

    Seq Age Sex Outcome Treatment
    1 Other