BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12611407 · Received October 11, 2021

    Report

    Report Number
    9610877-2021-01016
    Event Type
    Malfunction
    Date Received
    October 11, 2021
    Report Date
    December 8, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    UDI-DI
    04961333129492
    PMA / PMN Number
    K131902
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: IT WAS DETERMINED THAT THE CAUSE WAS THE FAILURE OF THE DRIVER BOARD DUE TO LIQUID INTRUSION INTO THE PVE CONNECTOR. CORRECTION INFORMATION: G6: FOLLOW UP #1. H2: TYPE OF FOLLOW UP. H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT.

    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 A COMPLAINT WHICH OCCURRED IN THE UNITED STATES WITHIN THE PAI REGION STATING "THERE WAS NO VIDEO IMAGE" INVOLVING PENTAX MEDICAL VIDEO GASTROSCOPE MODEL EG-2990I, SERIAL NUMBER (B)(4). THE CUSTOMER STATED NO VIDEO IMAGE OR LIVE VIDEO FEED DISPLAYS WHEN THE SCOPE IS HOOKED UP TO THE PROCESSORS. IT ONLY DISPLAYS THE MESSAGE "CHECK SCOPE CONNECTION". IT WAS FIRST OBSERVED DURING A PRE-PROCEDURE SCOPE TESTING/CHECK. THE CUSTOMER REPORTED THAT THERE WAS NO OBVIOUS CAUSE FOR THE ISSUE AND NO INJURY TO STAFF OR PATIENTS FROM THE PROBLEM. THERE WAS NO REPORT OF SERIOUS INJURY, DELAY IN PROCEDURE OR REQUIRED MEDICAL INTERVENTION. THE CUSTOMER OWNED ENDOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 22-SEP-2021. THE ENDOSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE UNDER SERVICE ORDER (B)(4) AND THE TECHNICIAN CONFIRMED THE CUSTOMER COMPLAINT OF IMAGE BLACKOUT AND ALSO DOCUMENTED THE FOLLOWING INSPECTION FINDINGS: ,SIDE BODY COVER O-RING STICKING OUT, FLUID INVASION IN CONTROL BODY, INSERTION TUBE BUCKLES AT END OF ROOT BRACE, PVE ELECTRICAL PIN CORRODED, CCD CIRCUIT BOARD CORROSION, PRIMARY OPERATION CHANNEL RESISTANCE, UP ANGULATION DECREASED, RIGHT ANGULATION DECREASED, FAILED DRY LEAK TEST, WET LEAK TEST NOT PERFORMED UNIT COMPROMISED, PVE ELECTRICAL CONNECTOR FRAME HAS SEVERE CORROSION, UMBILICAL CABLE BUMP, LEAK AT SIDE BODY COVER, IMAGE BLACKOUT, FLUID INVASION IN SEGMENT SECTION, FLUID DAMAGE TO LIGHT CARRYING BUNDLE, CORE HOLDING PLATE CORRODED, FLUID INVASION IN PVE CONNECTOR, # 2 REMOTE CONTROL BUTTON COVER CRACKED, # 1 REMOTE CONTROL BUTTON COVER CRACKED, FLUID INVASION TO INSERTION TUBE, LEFT ANGULATION DECREASED, DOWN ANGULATION DECREASED, AIR/ WATER SOCKET CYLINDER O-RING CHIPPED, CORE CORRODED, FLUID INVASION IN UMBILICAL LIGHT GUIDE CABLE, SHIELD COVER CORRODED, CONTROL BODY CORRODED. THE DEVICE UNDERWENT REPAIRS INCLUDING THE FOLLOWING COMPONENTS: O-RINGS AND SEALS, DISTAL END ASSY WITH TUBES, LIGHT GUIDE FIBER BUNDLE (LCB), 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, CONNECTING RECEPTACLE(2), CONNECTING RECEPTACLE, INTERMEDIATE PLATE, PCB FOR R.C SWITCH PB-FREE, REMOTE CONTROL BUTTON, SWITCH WITH BASE PLATE NO1 PB-FREE, SWITCH WITH BASE PLATE NO2 PB-FREE, LIGHT GUIDE CABLE, PCB FOR CCD DRIVE PB-FREE, ELECTRICAL CONNECTOR ASSY, SHIELD PIPE FOR CCD, SIGNAL WIRE FOR CCD, CONDUCTIVE PLATE, BASE PLATE. THE ENDOSCOPE IS AWAITING REPAIR COMPLETION AND APPROVED BY FINAL QC AS OF 11-OCT-2021. MODEL EG-2990I, SERIAL NUMBER (B)(4) HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE. ON 24-SEP-2021, A DEVICE HISTORY RECORD(DHR) REVIEW FOR MODEL EG-2990I, SERIAL NUMBER (B)(4) WAS PERFORMED BY THE MANUFACTURER. THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED IN THE (B)(4) FACILITY ON 21-JUL-2010 UNDER NORMAL CONDITIONS, PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. ALSO, THERE WERE NO REWORKS OR CONCESSIONS AND THE DATES OF APPROVAL FOR SHIPMENT AND ACTUAL DATE SHIPPED WERE CONFIRMED FOR 21-JUL-2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504919 PENTAX HD VIDEO GASTROSCOPE 2.8C 9.8T 1050L FDS HOYA CORPORATION PENTAX TOKYO OFFICE EG-2990I 04961333129492

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown