BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12468084 · Received September 14, 2021

    Report

    Report Number
    9610877-2021-00789
    Event Type
    Malfunction
    Date Received
    September 14, 2021
    Date of Event
    August 17, 2021
    Report Date
    September 14, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. SIMILAR MODEL EC38-I10L-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K13185. (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 SCOPE EC38-I10L. IN THE EVENT REPORTED, IT WAS STATED THAT THERE WAS NO VIDEO/ERROR MSG, SCOPE NOT CONNECTED. THE ANOMALY OCCURRED IN THE PROCEDURE ROOM DURING USE. THE CUSTOMER STATED THE CAMERA IS NOT WORKING AT DISTAL END. THE CUSTOMER ALSO STATED THERE WERE NO PATIENT/USER INJURIES, ADVERSE EVENTS, DELAY, OR MEDICAL INTERVENTION REPORTED. THE DEVICE WAS RETURNED TO PENTAX MEDICAL SERVICE FACILITY ON SERVICE ORDER (B)(4) WHERE IT WAS INSPECTED, AND THE USER NARRATIVE WAS NOT CONFIRMED. THE INSPECTION FINDINGS ARE AS FOLLOWS: OPERATION CHANNEL- PRIMARY SHORT; PASSED DRY LEAK TEST; PASSED WET LEAK TEST; CUSTOMER COMPLAINT NOT DUPLICATED; INSERTION TUBE SNAKY WHEN ANGULATED; AIR/ WATER SOCKET O-RING CHIPPED. THE DEVICE CURRENTLY PENDING REPAIRS AND WILL BE RETURNED TO THE USER UPON COMPLETION. PARTS TO BE REPLACED: O-RINGS AND SEALS; BENDING RUBBER; RL PULLEY ASSY; UD PULLEY ASSY; ADJUSTING COLLAR; ANGLE WIRE; OPERATION CHANNEL; PCB FOR CCD DRIVE PB-FREE; ELECTRICAL CONNECTOR ASSY A REVIEW OF THE SERVICE HISTORY INDICATES THE DEVICE WAS ROUTINELY SERVICED AT A PENTAX SERVICE FACILITY. ON 08-SEP-2021, A DEVICE HISTORY RECORD (DHR) REVIEW FOR MODEL EC38-I10L, SERIAL NUMBER (B)(4) WAS PERFORMED AND THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED ON 08SEP2015 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. NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364468 PENTAX VIDEO COLONOCOPE - I10 STANDARD FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC38-I10L

    Patients

    Seq Age Sex Outcome Treatment
    1