BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12351910 · Received August 21, 2021

    Report

    Report Number
    9610877-2021-00735
    Event Type
    Malfunction
    Date Received
    August 21, 2021
    Report Date
    August 21, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    UDI-DI
    04961333228430
    PMA / PMN Number
    K131855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS COMPLAINT IS BEING PROCESSED IN ACCORDANCE WITH DPA-QIP-MDR DECISION BACKLOG MANAGEMENT PLAN. 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 STATING "NOT ABLE TO GET FORCEPS THRU INLET PORT" INVOLVING PENTAX MEDICAL VIDEO COLONOSCOPE MODEL EC-3890LI, SERIAL NUMBER (B)(4). THE EVENT WAS REPORTED TO OCCUR IN THE OPERATING ROOM, DURING USE. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR OTHER SIGNIFICANT/IMPORTANT MEDICAL EVENT. THE MANUFACTURE, MODEL AND LOT NUMBER OF THE FORCEPS ARE UNKNOWN. THE CUSTOMER OWNED ENDOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 04-FEB-2021. THE ENDOSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE UNDER SERVICE ORDER (B)(4) AND DURING QUALITY INSPECTION THE TECHNICIAN DID NOT FIND ANY STUCK OR BROKEN ACCESSORIES BUT DID FIND PRIMARY OPERATION CHANNEL RESISTANCE AND SUCTION TUBE MILD RESISTANCE AS WELL AS DOCUMENTEING THE FOLLOWING INSPECTION FINDINGS: PASSED DRY LEAK TEST AND PASSED WET LEAK TEST. THE DEVICE UNDERWENT REPAIRS INCLUDING THE FOLLOWING COMPONENTS: O-RINGS AND SEALS, OPERATION CHANNEL, ADJUSTING COLLAR, BENDING RUBBER, ANGLE WIRE, SUCTION CHANNEL LG, O-RING (1.8X19.8), GLASS ROD ASSY. THE ENDOSCOPE WAS APPROVED BY FINAL QC ON 08-MAR-2021 AND DELIVERED TO THE CUSTOMER UNDER DELIVERY ORDER (B)(4). MODEL EC-3890LI, SERIAL NUMBER (B)(4), HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1249171 PENTAX HDVIDEO COLONOSCOPE 3.8C 13.2T 1700L FWJ FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC-3890LI 04961333228430

    Patients

    Seq Age Sex Outcome Treatment
    1