BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12351845 · Received August 21, 2021

    Report

    Report Number
    9610877-2021-00485
    Event Type
    Malfunction
    Date Received
    August 21, 2021
    Date of Event
    January 1, 2021
    Report Date
    December 7, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EQL
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY:NO INFORMATION WAS AVAILABLE TO IDENTIFY THE CAUSE. THE ASSUMED CAUSE IS THE BREAKAGE OF THE CCD CABLE DUE TO THE LOAD FROM REPEATED USE OF THE ENDOSCOPE.CORRECTION INFORMATIONG6: FOLLOW UP #1H2: TYPE OF FOLLOW UPH6: CODING CHANGED BASED ON THE INVESTIGATION RESULTADDITIONAL INFORMATIONH4: DEVICE MANUFACTURE DATE

    Additional Manufacturer Narrative · 1

    PENTAX MODEL VLS-1190STK IS CLASSIFIED AS EXEMPT, THEREFORE 510K IS NOT APPLICABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Description of Event or Problem · 1

    PENTAX MEDICAL BECAME AWARE OF A REPORT FOR AN EVENT WHICH OCCURRED IN THE USA STATING, " NO VIDEO IMAGE. THE IMAGE CUTTING IN/OUT" INVOLVING PENTAX MODEL VLS-1190STK/ A110302. THE USER STATED THE EVENT OCCURRED DURING PRE-INSPECTION CHECK. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF THE REPORT. THE DEVICE WAS RETURNED TO PENTAX FOR EVALUATION. PENTAX SERVICE INSPECTIONAL FINDINGS INCLUDED: PASSED WET LEAK TEST, PASSED DRY LEAK TEST. THE CUSTOMER COMPLAINT WAS NOT CONFIRMED. THE DEVICE WAS REPAIRED WHICH INCLUDED REPLACEMENT OF THE FOLLOWING COMPONENTS: O-RINGS AND SEALS, PCD FOR CCD DRIVE SU K3A PB-FREE, ELECTRICAL CONNECTOR ASSY. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1249271 PENTAX VIDEO LARYNGOSTROBOSCOPE EQL HOYA CORPORATION PENTAX TOKYO OFFICE VLS-1190STK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown