BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD AUTOCLAVABLE CAMERA HEAD

    MDR report key: 6581027 · Received May 22, 2017

    Report

    Report Number
    8010047-2017-00621
    Event Type
    Malfunction
    Date Received
    May 22, 2017
    Date of Event
    February 6, 2017
    Report Date
    March 7, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    PK955404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OMSC INVESTIGATED THE SUBJECT DEVICE AND CONFIRMED THE FOLLOWING. HORIZONTAL LINE NOISE OCCURRED IN THE ENDOSCOPIC IMAGE. THIS NOISE OCCURRED DURING THE ELECTRONIC SHUTTER WAS ENABLED. THIS NOISE DID NOT OCCUR DURING THE ELECTRONIC SHUTTER WAS DISABLED. BASED UPON THE INVESTIGATION RESULT, OMSC SURMISED THAT THIS PHENOMENON WAS CAUSED BY THE FOLLOWING MECHANISM. REGARDING THE VIDEO SIGNAL SENT TO THE CCD UNIT OF THE SUBJECT DEVICE, THE DISTURBANCE OCCURRED DURING THE ELECTRONIC SHUTTER WAS ENABLED DUE TO THE INFLUENCE OF ANY CHARACTERISTIC VARIATION OF THE DEVICE CONTROLLING THE ELECTRONIC SHUTTER ON THE CIRCUIT BOARD OF THE SUBJECT DEVICE. THE NOISE OCCURRED BY THIS DISTURBANCE OF THE VIDEO SIGNAL. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS SUBMITTING TO CORRECT "DEVICE PRODUCT CODE".

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING THE TUR-P PROCEDURE, THE ENDOSCOPIC IMAGE WAS BLINKED. THE FACILITY CHANGED THE ENDOSCOPIC SYSTEM TO THE SIMILAR BUT OTHER SYSTEM AND THE PHYSICIAN COMPLETED THE PROCEDURE. AT FIRST, THE FACILITY THOUGHT THAT THE CLV-S190 HAD ABNORMALITY, THEREFORE OCM REPAIRED THE CLV-S190, HOWEVER THE IMAGE ABNORMALITY COULD NOT BE RESOLVED. WHEREAFTER OCM CHECKED THE OTV-S7PROH-HD-12E WHICH WAS USED WITH THE SUBJECT CLV-S190 IN THE PROCEDURE AND FOUND THAT THE REPORTED PHENOMENON WAS CAUSED BY THE DEFECT IN THE OTV-S7PROH-HD-12E ON APRIL 26 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364496 HD AUTOCLAVABLE CAMERA HEAD CAMERA HEAD FET OLYMPUS MEDICAL SYSTEMS CORP. OTV-S7PROH-HD-12E

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR