BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD AUTOCLAVABLE CAMERA HEAD

    MDR report key: 6412301 · Received March 17, 2017

    Report

    Report Number
    8010047-2017-00306
    Event Type
    Malfunction
    Date Received
    March 17, 2017
    Date of Event
    December 12, 2016
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    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 ON 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

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. OMSC EVALUATED THE DEVICE AND FOUND THE FOLLOWING. THE PHENOMENON WAS NOT FLARE BUT IMAGE NOISE. THE IMAGE NOISE WAS REPRODUCED WHEN THE DISTANCE BETWEEN A TARGET OBJECT AND A TIP OF SCOPE WAS SHORT. OMSC IS CONTINUING THE INVESTIGATION OF THIS CASE. OMSC CHECKED THE DEVICE HISTORY RECORD OF THE SUBJECT DEVICE, AND THERE WAS NO IRREGULARITY FOUND. THE OTV-S7PROH-HD-12E INSTRUCTION MANUAL STATES THE CORRESPONDING METHOD WHEN THERE IS AN ABNORMALITY. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    ON DECEMBER 12TH 2016, OLYMPUS WAS INFORMED THE FOLLOWING INFORMATION. DURING AN UNSPECIFIED PROCEDURE, WHEN THE USER FACILITY MOVED THE SUBJECT DEVICE QUICKLY, FLARE OCCURRED ON THE ENDOSCOPIC IMAGE. AS A RESULT OF ADDITIONAL SURVEY, OLYMPUS WAS INFORMED THE FOLLOWING INFORMATION ON FEBRUARY 15TH 2017. INTENDED PROCEDURE WAS PLASMAKINETIC RESECTION. THIS EVENT OCCURRED DURING THE PROCEDURE. THE USER FACILITY REPLACED THE SUBJECT DEVICE WITH A SPARE DEVICE MADE BY ANOTHER COMPANY, AND COMPLETED THE PROCEDURE. THERE WAS NO REPORT OF THE PATIENT¿S INJURY REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197914 HD AUTOCLAVABLE CAMERA HEAD CAMERA HEAD FET OLYMPUS MEDICAL SYSTEMS CORP. OTV-S7PROH-HD-12E

    Patients

    Seq Age Sex Outcome Treatment
    1