BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 6644957 · Received June 15, 2017

    Report

    Report Number
    9610877-2017-00042
    Event Type
    Malfunction
    Date Received
    June 15, 2017
    Report Date
    September 1, 2016
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    MNL
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PRODUCT CODE IS CLASS 1, EXEMPT FROM FDA 510K. THIS MDR WAS INITIATED AS PART OF A CAPA-DRIVEN REMEDIATION EFFORT RELATED TO FILING OF MDRS FOR COMPLAINTS/EVENTS RELATED TO LODGED MATERIAL REMAINING IN ENDOSCOPES AFTER REPROCESSING. AS PART OF THIS REMEDIATION, PENTAX MEDICAL PERFORMED A RETROSPECTIVE MDR ASSESSMENT OF EVENTS/COMPLAINTS RECEIVED FROM (B)(6) 2014-(B)(6) 2016. THE RETROSPECTIVE ASSESSMENT OF THIS EVENT PROMPTED PENTAX MEDICAL TO FILE THIS REPORT. (EXEMPTION NUMBER E2015036).

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT FOR AN EVENT WHICH OCCURRED IN (B)(6) STATING ON (B)(6) 2016 "A SECTION OF THE BRUSH WAS FOUND INSIDE AN ENDOSCOPE AFTER HIGH LEVEL DECONTAMINATION (HLD) BY THE SURGICAL REPROCESSOR WHO THOUGHT IT MAY HAVE BROKEN OFF AND REMAINED IN THE SCOPE CHANNEL DURING HLD" INVOLVING PENTAX MODEL CS-6021T/LOT 0011076. NO OTHER INFORMATION WAS PROVIDED AT THE TIME OF THE REPORT. THE BROKEN BRISTLE PORTION OF THE BRUSH WAS RETURNED TO PENTAX MEDICAL. INFORMATION ON THE ENDOSCOPE INVOLVED IN THE EVENT WAS NOT RECEIVED BY PENTAX. THE INSTRUCTIONS FOR USE FOR THIS PENTAX MODEL BRUSH SPECIFICALLY STATES, "AFTER USING, CAREFULLY CHECK THAT NO PARTS OF BRUSHES HAVE FALLEN OFF INSIDE THE ENDOSCOPE'S SUCTION CHANNEL. IF THE INSPECTION DETERMINES THAT BRISTLES OR A DISTAL END (BLUE) HAVE COME OFF DURING CLEANING, IMMEDIATELY RETRIEVE THEM BY FLUSHING CLEAN WATER THROUGH THE CHANNEL WITH A SYRINGE. ANY PART OF THE BRUSH REMAINING IN THE CHANNEL AFTER CLEANING MAY DROP INTO THE PATIENT'S BODY DURING A SUBSEQUENT PROCEDURE. DEPENDING ON THE LOCATION OF A DETACHED PART, IT CANNOT BE FLUSHED AWAY BY CLEAN WATER THROUGH THE CHANNEL WITH A SYRINGE. IN THIS CASE, CONTACT YOUR LOCAL PENTAX SALES FACILITY". A CORRECTIVE ACTION REQUEST ((B)(4)) WAS PREVIOUSLY ISSUED FOR THE MANUFACTURE TO FURTHER INVESTIGATE THIS TYPE OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425814 PENTAX ENDOSCOPE CLEANING BRUSH (GI) MNL HOYA CORPORATION PENTAX TOKYO OFFICE CS-6021T 0011076

    Patients

    Seq Age Sex Outcome Treatment
    1