BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIA COMPLIANCE KIT

    MDR report key: 8073345 · Received November 15, 2018

    Report

    Report Number
    1528319-2018-00037
    Event Type
    Malfunction
    Date Received
    November 15, 2018
    Date of Event
    October 15, 2018
    Report Date
    November 15, 2018
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Product Code
    NWU
    UDI-DI
    00816765012390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED DURING AN UPPER EGD SAMPLING PROCEDURE. A FORCEPS DEVICE WAS INSERTED THROUGH THE ENDOSCOPE ACCESSORY CHANNEL AND PUSHED THE BRUSH HEAD INTO THE DUODENUM. THE BRUSH HEAD PASSED INTO THE SMALL INTESTINE AND THE PHYSICIAN DID NOT ATTEMPT RETRIEVAL. THE DOUBLE-HEADER CLEANING BRUSH IS INCLUDED WITHIN THE VIA COMPLIANCE KIT. THE LOT NUMBERS OF THE PROCEDURE KIT AND THE CLEANING BRUSH ARE UNKNOWN. THE DEVICE SUBJECT OF THIS EVENT WAS NOT RETURNED TO US ENDOSCOPY FOR EVALUATION. THE INSTRUCTIONS FOR USE INCLUDE THE FOLLOWING STATEMENTS: "IF THE CHANNELS ARE KNOWN TO BE OCCLUDED OR RESISTANCE IS MET IN ATTEMPTING TO PASS THE BRUSH THROUGH THE ENDOSCOPE, DO NOT FORCE THE CLEANING BRUSH THROUGH THE ENDOSCOPE. USE ONLY IN CHANNELS 2.0MM AND LARGER AND IN CONTROL HEAD VALVE OPENINGS. DISPOSE OF THE CLEANING BRUSH AFTER INITIAL USE. THE MECHANICAL ATTACHMENT OF THE BRUSH(ES) TO THE PLASTIC SHEATH CANNOT BE GUARANTEED TO BE RELIABLE OR SECURE FOLLOWING INITIAL USE." THE FACILITY ACCEPTED US ENDOSCOPY'S OFFER OF IN-SERVICE TRAINING. THE TRAINING WAS COMPLETED ON (B)(6) 2018; NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE BRUSH HEAD OF A DOUBLE-HEADER CLEANING BRUSH BECAME DETACHED DURING CLEANING AND WAS RETAINED IN THE ENDOSCOPE ACCESSORY CHANNEL. THE BRUSH HEAD WAS PUSHED INTO THE PATIENT DURING THE NEXT PROCEDURE. THE PHYSICIAN CHOSE NOT TO RETRIEVE THE BRUSH HEAD, INSTEAD ALLOWING IT TO PASS NATURALLY. THERE WAS NO REPORTED HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912395 VIA COMPLIANCE KIT COMPLIANCE KIT NWU UNITED STATES ENDOSCOPY GROUP, INC. 00719701 00816765012390

    Patients

    Seq Age Sex Outcome Treatment
    1