BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12242869 · Received July 28, 2021

    Report

    Report Number
    9610877-2021-00386
    Event Type
    Malfunction
    Date Received
    July 28, 2021
    Report Date
    July 28, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    UDI-DI
    04961333172085
    PMA / PMN Number
    K131902
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A COMPLAINT TO CUSTOMER SERVICE ON 29-JUN-2021 FOR A "NO VIDEO IMAGE" THAT OCCURRED IN THE UNITED STATES INVOLVING PENTAX MEDICAL VIDEO GASTROSCOPE, MODEL EG-2990I, SERIAL NUMBER (B)(4). THE USER RESPONDED TO CUSTOMER SERVICE GOOD FAITH EFFORT QUESTIONS ON 29-JUN-2021 AND THE USER STATED THAT THE EVENT WAS REPORTED TO OCCUR DURING USE AND THERE WERE NO ACCESSORIES USED. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR OTHER SIGNIFICANT/IMPORTANT MEDICAL EVENT. THE CUSTOMER OWNED ENDOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 02-JUL-2021. THE ENDOSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE UNDER SERVICE ORDER (B)(4) AND THE TECHNICIAN COULD NOT CONFIRM THE CUSTOMERS COMPLAINT BUT DID DOCUMENTED THE FOLLOWING INSPECTION FINDINGS ON 08-JUL-2021: INSERTION TUBE BUCKLES AT END OF ROOT BRACE, FAILED WET LEAK TEST, SEGMENT STEEL BRAID CUT, SUCTION TUBE RESISTANCE, ETO VENT VALVE LOOSE INNER SHAFT, UNAUTHORIZED ADJUSTMENT OF A/W NOZZLE - SHARP EDGES EXPOSED, CE MARKING PLATE MISSING, FAILED DRY LEAK TEST, AIR/ WATER SOCKET WORN THREAD, BENDING RUBBER PINHOLE, UMBILICAL CABLE SINGLE BUCKLED UNDER PVE ROOT BRACE, HOLE IN # 2 REMOTE CONTROL BUTTON COVER, FLUID INVASION NOT OBSERVED IN PVE CONNECTOR, FLUID INVASION NOT OBSERVED IN CONTROL BODY, BENDING RUBBER LEAK AT PROXIMAL SIDE, AIR/ WATER SOCKET CYLINDER O-RING CHIPPED, DISTAL BODY CHIP AT CHANNEL OPENING AT THINNEST PART. THE DEVICE UNDERWENT REPLACEMENTS FOR THE FOLLOWING COMPONENTS: O-RINGS AND SEALS, DISTAL END ASSY WITH TUBES, CCD-M W/DRIVE PCB PB-FREE, ADJUSTING COLLAR, BENDING RUBBER, DISTAL ATTACHING PLATE, SEGMENT ASSY ATTACHING SCREW, INSERTION FLEX TUBE, SEGMENT ATTACHING SCREW, STAYCOIL COLLAR, SEGMENT STAYCOIL ASSY PB-FREE, RL PULLEY ASSY, UD PULLEY ASSY, REMOTE CONTROL BUTTON, AIR/WATER SUPPLY TUBE LG, JET SUPPLY TUBE LG, SUCTION CHANNEL LG, EOG VALVE ASSY, EOG VALVE TIGHTENING SCREW IMP-1, LIGHT GUIDE CABLE, ELECTRICAL CONNECTOR ASSY, MFR LABEL E-HOYA W/CE0123 (S). MODEL EG-2990I, SERIAL NUMBER (B)(4), HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE ON 12-NOV-2008. THE ENDOSCOPE IS PENDING REPAIR AND APPROVAL BY FINAL QC AS OF 28-JUL-2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1135899 PENTAX VIDEO GASTROSCOPE FDS HOYA CORPORATION PENTAX TOKYO OFFICE EC38-I10L 04961333172085

    Patients

    Seq Age Sex Outcome Treatment
    1