BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 11859879 · Received May 20, 2021

    Report

    Report Number
    9610877-2021-00097
    Event Type
    Malfunction
    Date Received
    May 20, 2021
    Report Date
    April 20, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    UDI-DI
    04961333211692
    PMA / PMN Number
    K131902
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4)

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF AN EVENT ON 20-APR-2021 THAT OCCURRED AT A FACILITY DURING USE IN THE UNITED STATES. THE REPORTED COMPLAINT THAT AN ACCESSORY BECAME STUCK IN THE SCOPE DURING A PROCEDURE INVOLVING PENTAX MEDICAL VIDEO GASTROSCOPE MODEL EG29-I10, SERIAL NUMBER (B)(4). ADDITIONALLY THE REPORTER IDENTIFIED THE ACCESSORY AS BOSTON SCIENTIFIC FORCEPS, UNKNOWN MODEL AND LOT NUMBER. NO SERIOUS INJURY OR DEATH OF A PATIENT OR USER, OR DELAY IN THE PROCEDURE WHICH WOULD REQUIRE MEDICAL INTERVENTION WAS REPORTED. THE USER FACILITY RESPONDED TO A GOOD FAITH EFFORT(GFE) REQUEST VIA EMAIL ON 23-APR-2021 STATING THAT THE DEVICE GOT STUCK AT THE END OF THE CURRENT PROCEDURE AND THE ENDOSCOPE WAS REMOVED FROM CIRCULATION IMMEDIATELY AFTER THE FAILURE/EVENT OCCURRED AND SUBSEQUENTLY CALLED IN FOR SERVICE/REPLACEMENT. PATIENT INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE CUSTOMER OWNED ENDOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 23-APR-2021. THE ENDOSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE UNDER SERVICE ORDER (B)(4) AND THE TECHNICIAN CONFIRMED AN "ACCESSORY STUCK IN PRIMARY OPERATION CHANNEL" AND ALSO DOCUMENTED THE FOLLOWING INSPECTION FINDINGS ON 27-APR-2021: DISTAL BODY CHIP AT CHANNEL OPENING AT THINNEST PART, LEFT LIGHT CARRYING BUNDLE DISTAL COVER GLASS CRACKED, PASSED WET LEAK TEST, PASSED DRY LEAK TEST, OPERATION CHANNEL- PRIMARY SLICE BY ACCESSORY, HOLE IN # 2 REMOTE CONTROL BUTTON COVER, IMAGE MILD SPOT, BIOPSY INLET T-PIECE BENT. THE DEVICE UNDERWENT REPAIRS INCLUDING THE FOLLOWING COMPONENTS: O-RINGS AND SEALS, BENDING RUBBER, DISTAL END ASSY WITH TUBES, REMOTE CONTROL BUTTON CASE (2), BIOPSY INLET T-PIECE PB-FREE, AIR/WATER SUPPLY TUBE LG, JET SUPPLY TUBE LG, O-RING (1.8X19.8), ANGLE WIRE, SHIELD PIPE FOR CCD. INSTRUCTIONS FOR USE(IFU), INCLUDES THE FOLLOWING WARNING SECTION 2-1-3, 3) "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. PENTAX MEDICAL MODEL EG29-I10, SERIAL NUMBER (B)(4) HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE ON 23-MAR-2016. THE ENDOSCOPE IS AWAITING REPAIR AND APPROVED BY FINAL QC AS OF 20-MAY-2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751950 PENTAX VIDEO GASTROSCOPE FDS HOYA CORPORATION PENTAX TOKYO OFFICE EG29-I10 04961333211692

    Patients

    Seq Age Sex Outcome Treatment
    1