BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12453932 · Received September 10, 2021

    Report

    Report Number
    9610877-2021-00628
    Event Type
    Malfunction
    Date Received
    September 10, 2021
    Date of Event
    August 12, 2021
    Report Date
    October 19, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    ODG
    PMA / PMN Number
    K182004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION: G6: FOLLOW UP #1. H2:IF FOLLOW-UP, WHAT TYPE? H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT (HEALTH EFFECT - CLINICAL CODE, HEALTH EFFECT - IMPACT CODE). ADDITIONAL INFORMATION: H4:DEVICE MANUFACTURE DATE.

    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

    PENTAX MEDICAL WAS MADE AWARE OF AN EVENT WHICH OCCURRED IN THE PAI REGION INVOLVING PENTAX VIDEO ULTRASOUND SCOPE EG-3670URK. IN THE EVENT REPORTED, IT WAS STATED THAT THERE WAS NO VIDEO IMAGE. THE EVENT TIMING OF THIS ANOMALY IS UNKNOWN. THERE WAS NO ADVERSE EVENT REPORTED WITH THIS COMPLAINT. THE DEVICE WAS RETURNED TO PENTAX MEDICAL SERVICE FACILITY ON SERVICE ORDER (B)(4) WHERE IT WAS EVALUATED, AND THE USER NARRATIVE WAS CONFIRMED. INSPECTION FINDINGS ARE AS FOLLOWS: FLUID INVASION IN CONTROL BODY; ENDOSCOPE FAILED ELECTRICAL SAFETY TEST - PLCT; PASSED WET LEAK TEST FLUID INVASION IN MIDDLE LCB DISTAL COVER GLASS; IMAGE BLACKOUT; FLUID INVASION IN ULTRASOUND CONNECTOR; FLUID INVASION IN SEGMENT SECTION; PVE CONNECTOR HOUSING CORRODED; FAILED DRY LEAK TEST; PVE ELECTRICAL CONNECTOR FRAME HAS SEVERE CORROSION; ENDOSCOPE FAILED ELECTRICAL SAFETY TEST - HI-POT; UP STAY COIL CORRODED; RIGHT STAY COIL CORRODED; LEFT STAY COIL CORRODED; DOWN STAY COIL CORRODED; ULTRASOUND CONNECTOR BODY CORROSION ON MAIN CIRCUIT BOARD; FLUID INVASION IN PVE CONNECTOR; ULTRASOUND CONNECTOR CASING DISCOLORATION; ULTRASOUND CONNECTOR CABLE SINGLE/ LONG FLUID INVASION; ULTRASOUND CONNECTOR CABLE SHORT FLUID INVASION; CORRODED ULTRASOUND CONNECTOR BODY; FLUID INVASION TO INSERTION TUBE; CORE HOLDING PLATE CORRODED; PVE ELECTRICAL PIN CORRODED; CCD CIRCUIT BOARD CORROSION; CORE CORRODED; FLUID INVASION IN UMBILICAL LIGHT GUIDE CABLE; SHIELD COVER CORRODED; FLUID DAMAGE TO LIGHT CARRYING BUNDLE; LEAK AT ELEVATOR WASHING SOCKET CYLINDER THE DEVICE IS IN THE PROCESS OF BEING REPAIRED AND WILL BE RETURNED TO THE USER UPON COMPLETION. PARTS TO BE REPLACED: O-RINGS AND SEALS; STAYCOIL COLLAR; INSERTION FLEXIBLE TUBE; DEFLECTOR OPERATING WIRE; DEFLECTOR STAY TUBE ASSY PB-FREE; DISTAL ATTACHING PLATE; SEGMENT ASSY ATTACHING SCREW; BENDING RUBBER; OPERATION CHANNEL; AIR/WATER TUBE; ADJUSTING COLLAR; CONNECTING RECEPTACLE (1); CCD-M W/PCB ASSY PB-FREE/NTSC; LIGHT GUIDE FIBER BUNDLE(LCB); LCB DISTAL COVER GLASS; US CONNECTOR BODY PB-FREE; SUCTION CHANNEL LG; AIR/WATER SUPPLY TUBE LG; CONTROL BODY COMPLETE PB-FREE; INTERMEDIATE PLATE; STAYCOIL HOLDER BRACKET; BRACKET COVER; GUIDE COVER PLATE; U-STOPPER; D-STOPPER; R-STOPPER; L-STOPPER; REMOTE CONTROL WIRE PB-FREE; GND WIRE; LG CABLE CONNECTOR ASSY PB-FREE/NT; SHIELD COVER A REVIEW OF THE SERVICE HISTORY INDICATES THE DEVICE IS ROUTINELY SERVICED AT A PENTAX SERVICE FACILITY. NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1352989 PENTAX LINEAR ULTRASOUND VIDEO GASTROSCOPE ODG HOYA CORPORATION PENTAX TOKYO OFFICE EG-3270UK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown