BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD AUTOCLAVABLE CAMERA HEAD

    MDR report key: 7005040 · Received November 6, 2017

    Report

    Report Number
    8010047-2017-01658
    Event Type
    Malfunction
    Date Received
    November 6, 2017
    Date of Event
    August 30, 2017
    Report Date
    March 7, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    PK061313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OSP (OLYMPUS (B)(4)) CHECKED THE SUBJECT OTV-S7PROH-HD-10E USING THE ENDOSCOPIC SYSTEM INCLUDING THE OTV-S190 AND CLV-S190. THE FOLLOWING WAS FOUND. -THE NOISE ON THE IMAGE DID NOT APPEAR IMMEDIATELY AFTER CONNECTING TO THE ENDOSCOPIC SYSTEM. -WHEN THE SUBJECT OTV-S7PROH-HD-10E CONNECTED FOR ABOUT 30 MINUTES, THE ENDOSCOPIC IMAGE STARTED TO FLICKER INTERMITTENTLY AND NOISE BEGAN TO APPEAR. THE SUBJECT OTV-S7PROH-HD-10E WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP.(OMSC) FOR THE EVALUATION. OMSC CONTINUES TO INVESTIGATE THIS EVENT. OTV-S7PROH-HD-10E INSTRUCTION MANUAL STATES THE CORRESPONDING METHOD IN CASE OF AN ABNORMALITY. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS FOUND, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    OMSC TRIED TO REPRODUCE THIS PHENOMENON, HOWEVER THIS PHENOMENON WAS NOT REPRODUCED. OMSC PERFORMED THE FOLLOWING USING THE SUBJECT OTV-S7PROH-HD-10E AND THE OTV-S190 OWNED BY OMSC. IN ADDITION, OMSC PERFORMED THE FOLLOWING SIMILARLY AFTER OMSC EXCHANGED THE OTV-S190 TO THE OTV-S7PRO OWNED BY OMSC. AS A RESULT, THE ENDOSCOPIC IMAGE WAS DISPLAYED WITHOUT ANY PROBLEM. THE SUBJECT OTV-S7PROH-HD-10E WAS OPERATED FOR AN HOUR. THE SHOCK WAS APPLIED TO THE SUBJECT OTV-S7PROH-HD-10E. THE SUBJECT OTV-S7PROH-HD-10E WAS TESTED UNDER STATE OF HIGH AND LOW DEGREES C. -THE SUBJECT OTV-S7PROH-HD-10E WAS TESTED UNDER STATE OF HIGH AND LOW HUMIDITY. THERE WAS POSSIBILITY THAT THE NOISE OCCURRED IN THE ENDOSCOPIC IMAGE AS BELOW MECHANISM BASED ON CHECKING SIMILAR COMPLAINTS. THE GND POTENTIAL GREATLY FLUCTUATED DUE TO THE SIGNAL OF THE ELECTRONIC SHUTTER OF THE SUBJECT OTV-S7PROH-HD-10E. THE CCD DRIVING SIGNAL WAS DISTURBED BECAUSE OF THE FLUCTUATION OF THE GND POTENTIAL. THEREFORE, THE NOISE WAS OCCURRED IN THE ENDOSCOPIC IMAGE. OMSC COULD NOT IDENTIFY THE ROOT CAUSE BECAUSE THERE WAS NO ABNORMALITY IN THE SUBJECT OTV-S7PROH-HD-10E. BASED ON THESE INVESTIGATIONS, OMSC SURMISED THAT THIS PHENOMENON MIGHT HAVE BEEN OCCURRED BY THE FOLLOWING. THE ABNORMALITY WAS OCCURRED IN THE SIGNAL BETWEEN THE SUBJECT OTV-S7PROH-HD-10E AND THE POSSESSOR TEMPORARILY BECAUSE THERE WERE FOREIGN MATERIALS (E.G. MOISTURE) ADHERED TO THE CONNECTER OF THE SUBJECT OTV-S7PROH-HD-10E. THEREFORE THE NOISE WAS OCCURRED IN THE ENDOSCOPIC IMAGE. THE HIGH FREQUENCY CURRENT WAS GENERATED BECAUSE THE USER USED SUCH AS ELECTRICAL KNIFE. THE NOISE WHICH GENERATED BY HIGH FREQUENCY CURRENT INFLUENCED THE SIGNAL OF THE SUBJECT OTV-S7PROH-HD-10E. THEREFORE, THE NOISE WAS OCCURRED IN THE ENDOSCOPIC IMAGE. THE GND POTENTIAL GREATLY FLUCTUATED DUE TO THE SIGNAL OF THE ELECTRONIC SHUTTER OF THE SUBJECT OTV-S7PROH-HD-10E. THE CCD DRIVING SIGNAL WAS DISTURBED BECAUSE OF THE FLUCTUATION OF THE GND POTENTIAL. THEREFORE, THE NOISE WAS OCCURRED IN THE ENDOSCOPIC IMAGE. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS FOUND, 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 RECEIVED THE FOLLOWING REPORT ON SEP. 1, 2017. THE SUBJECT OTV-S7PROH-HD-10E WAS USED FOR UNSPECIFIED PROCEDURE. THE NOISE OCCURRED IN THE ENDOSCOPIC IMAGE WHEN THE USER CONNECTED THE SUBJECT OTV-S7PROH-HD-10E TO THE ENDOSCOPIC SYSTEM INCLUDING THE FOLLOWING DEVICES. -CLV-S190, -OTV-S190, -OEV262H. OLYMPUS GOT THE ADDITIONAL INFORMATION AS BELOW ON OCT. 17, 2017. THESE DEVICES WERE USED FOR THE RIGID CYSTOSCOPY. THE USER REPLACED THE SUBJECT OTV-S7PROH-HD-10E WITH ANOTHER OTV-S7H-1NA-10E 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
    782356 HD AUTOCLAVABLE CAMERA HEAD CAMERA HEAD FET OLYMPUS MEDICAL SYSTEMS CORP. OTV-S7PROH-HD-10E

    Patients

    Seq Age Sex Outcome Treatment
    1