BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 11043002 · Received December 19, 2020

    Report

    Report Number
    9610877-2020-00258
    Event Type
    Malfunction
    Date Received
    December 19, 2020
    Report Date
    December 3, 2020
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    MNL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MDR 9610877-2020-00257 IS BEING SUBMITTED FOR THE PENTAX MEDICAL VIDEO COLONOSCOPE MODEL EC34-I10L, SERIAL NUMBER (B)(4). MDR 9610877-2020-00258 IS BEING SUBMITTED FOR THE PENTAX MEDICAL CLEANING BRUSH, MODEL CS5522A, LOT NUMBER 0101910.

    Description of Event or Problem · 1

    PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON 19-NOV-2020 THAT OCCURRED DURING REPROCESSING. THE USER REPORTED A CLEANING BRUSH BECAME STUCK IN THE CHANNEL DURING REPROCESSING, INVOLVING THE PENTAX MEDICAL VIDEO COLONOSCOPE MODEL EC34-I10L, SERIAL NUMBER (B)(4). NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF THE REPORT. THE USER FACILITY REPLIED VIA EMAIL TO A GOOD FAITH EFFORT EMAIL ON 03-DEC-2020 STATING THAT THEY DID NOT HAVE THE ACCESSORY INFORMATION, BUT THE PRODUCT LABEL WAS RETURNED WITH THE DEVICE. NO PATIENT INVOLVEMENT WAS REPORTED. ON 03-DEC-2020, THE SERVICE REPAIR TEAM CONFIRMED THE BRUSH WAS A PENTAX MEDICAL ENDOSCOPE CLEANING BRUSH, MODEL CS5522A, LOT NUMBER 0101910, AND WOULD BE REPORTED TO THE FDA. THE CUSTOMER OWNED ENDOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 01-DEC-2020. DURING EVALUATION OF THE ENDOSCOPE UNDER SERVICE ORDER (B)(4), THE PENTAX MEDICAL SERVICE REPAIR TECHNICIAN FOUND AN "ACCESSORY STUCK IN SUCTION TUBE" CONFIRMING THE CUSTOMER'S COMPLAINT AND DOCUMENTING THE FOLLOWING ADDITIONAL FINDINGS ON 02-DEC-2020: PASSED WET LEAK TEST, SUCTION FUNCTION LOW FLOW, SUCTION TUBE RESISTANCE, BENDING RUBBER GLUE CRACKING AT INSERTION TUBE SIDE, PASSED DRY LEAK TEST, BENDING RUBBER MILD DISCOLORATION, AIR/ WATER NOZZLE GLUE WORN, RIGHT /LEFT ANGULATION KNOB PLAY, UP/ DOWN ANGULATION KNOB PLAY. THE DEVICE UNDERWENT REPAIRS INCLUDING THE FOLLOWING COMPONENTS: O-RINGS AND SEALS, BENDING RUBBER, SUCTION CHANNEL LG. 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. THIS IS THE FIRST TIME PENTAX MODEL EC34-I10L, SERIAL NUMBER (B)(4) HAS BEEN RETURNED FOR SERVICE AT A PENTAX MEDICAL FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE ON (B)(6) 2018. THE ENDOSCOPE WAS DELIVERED TO THE CUSTOMER ON (B)(6) 2020 UNDER DELIVERY ORDER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1507448 PENTAX CLEANING BRUSH MNL HOYA CORPORATION PENTAX TOKYO OFFICE CS5522A 0101910

    Patients

    Seq Age Sex Outcome Treatment
    1