BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12381227 · Received August 28, 2021

    Report

    Report Number
    9610877-2021-00135
    Event Type
    Malfunction
    Date Received
    August 28, 2021
    Report Date
    December 7, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    MNL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT IS BEING SUBMITTED FOR THE PENTAX MEDICAL CLEANING BRUSH, MODEL CS6021T, UNKNOWN SERIAL NUMBER. MDR 9610877-2021-00553 IS BEING SUBMITTED FOR THE PENTAX MEDICAL VIDEL GASTROSCOPE, MODEL EG29-I10, SERIAL NUMBER (B)(4). IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: THE CAUSE IS THOUGHT TO BE THAT THE BRUSH USED BY THE USER DURING CLEANING WAS BROKEN AND REMAINED IN THE PIPE. PENTAX HAS ADDED A METHOD FOR ALERTING AND DETECTING IN IFU IN THE EVENT, AND ALSO IMPLEMENTED FIELD ACTION. THE EVENT WAS NOT A CLOGGED FOREIGN OBJECT THAT WAS UNKNOWINGLY USED ON THE NEXT PATIENT, BUT WAS SUCCESSFULLY DETECTED AND A COMPLAINT WAS REPORTED.

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT THAT OCCURRED IN THE UNITED STATES WITH A DESCRIPTION OF "CUSTOMER REPORTED BRUSH STUCK/BROKEN IN CHANNEL. THE CUSTOMER STATED BRUSH IS BROKEN OFF INSIDE OF SCOPE DURING REPROCESSING" INVOLVING PENTAX ACCESSORY CLEANING BRUSH, MODEL CS-6021T, UNKNOWN LOT NUMBER. THE CLEANING BRUSH IDENTIFICATION WAS INITIALLY UNKNOWN, BUT OBTAINED AS NOTED BELOW. THE CLEANING BRUSH WAS USED TO REPROCESS PENTAX MEDICAL VIDEO GASTROSCOPE, MODEL EG29-I10, SERIAL NUMBER (B)(4). NO DEATH, INJURY OR SIGNIFICANT DELAY IN PROCEDURE WAS REPORTED. THE USER FACILITY INITIALLY RESPONDED TO A GOOD FAITH EFFORT REQUEST VIA EMAIL ON (B)(6) 2021 AND STATED THE ENDOSCOPE WAS REMOVED FROM CIRCULATION IMMEDIATELY AFTER THE FAILURE/EVENT OCCURRED AND SUBSEQUENTLY CALLED IN FOR SERVICE/REPLACEMENT AND THAT THE FACILITY FOLLOWS ALL IFUS AND PRE-PROCEDURAL INSPECTION CHECKS. THE FACILITY LATER RESPONDED ON 11-AUG-2021 AND CONFIRMED THE STUCK ACCESSORY WAS A PENTAX ACCESSORY CLEANING BRUSH, MODEL CS-6021T. INSTRUCTIONS FOR USE(IFU), INCLUDES THE FOLLOWING WARNING SECTION "AFTER USING OPERATIONAL/CLEANING ACCESSORIES (E.G., FORCEPS, NEEDLES, SNARES, BRUSHES ETC.) WITH THE ENDOSCOPE, CAREFULLY CHECK THAT ALL ACCESSORIES ARE INTACT AND THAT NO PARTS HAVE FALLEN OFF AND BECOME LODGED WITHIN THE ENDOSCOPE'S INSTRUMENT/SUCTION CHANNEL. FURTHERMORE, ENSURE THAT ANY THERAPEUTIC DEVICES (E.G., CLIPS, STENTS, ETC.) PASSED THROUGH THE CHANNEL ARE ACCOUNTED FOR AFTER USE. ON 06-APR-2016, PENTAX ISSUED A U.S. URGENT FIELD CORRECTION WHICH IS AN IFU ADDENDUM FOR ENDOSCOPES WITH INSTRUMENT CHANNELS. THIS ADDENDUM COVERS ANY OPERATIONAL/CLEANING ACCESSORIES AND THERAPEUTIC DEVICES WHICH CAN BECOME LODGED IN THE ENDOSCOPE'S INSTRUMENT CHANNEL. IT REMINDS CUSTOMERS TO CAREFULLY CHECK THAT ALL ACCESSORIES ARE INTACT, THAT NO PARTS HAVE FALLEN OFF AND BECOME LODGED WITHIN THE ENDOSCOPE'S INSTRUMENT/SUCTION CHANNEL AND TO ENSURE THAT ANY THERAPEUTIC DEVICES (E.G., CLIPS, STENTS, BALLOONS, ETC.) PASSED THROUGH THE INSTRUMENT CHANNEL AND ARE ACCOUNTED FOR AFTER USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1278440 PENTAX CLEANING BRUSHES (10 PER PACK) MNL HOYA CORPORATION PENTAX TOKYO OFFICE CS-6021T UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown