BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD AUTOCLAVABLE CAMERA HEAD

    MDR report key: 8815000 · Received July 23, 2019

    Report

    Report Number
    8010047-2019-02630
    Event Type
    Malfunction
    Date Received
    July 23, 2019
    Date of Event
    July 2, 2019
    Report Date
    October 18, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K102059
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A SUPPLEMENTAL REPORT TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. BASED ON AN EVALUATION RESULT SO FAR, OMSC DETERMINED THAT THE SUBJECT DEVICE MEETS THE SPECIFICATION AND SURMISED THAT THE REPORTED FAILURE PHENOMENON WAS ATTRIBUTED TO THE USER HANDLING OF THE DEVICES. THE CH-S190-XZ-Q INSTRUCTION MANUAL STATES THE CORRESPONDING METHOD WHEN THERE IS AN ABNORMALITY FOR THE DEVICE.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP.(OMSC) FOR EVALUATION. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS (B)(4) ((B)(4)). (B)(4) EVALUATED THE DEVICE AND FOUND THAT THERE WAS NO ABNORMALITY. THEREFORE THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED, IF ADDITIONAL OR SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING THE DECOMPRESSION WITH AC EXCISION (BEACH CHAIR PROCEDURE), THE UNSPECIFIED RIGID ENDOSCOPE CAME OFF FROM THE CH-S190-XZ-Q. THE USER CHANGED THE CH-S190-XZ-Q TO THE SECOND CH-S190-XZ-Q, HOWEVER THE RIGID ENDOSCOPE ALSO CAME OFF FROM THE SECOND CH-S190-XZ-Q. THE INTENDED PROCEDURE WAS COMPLETED WITH THE UNSPECIFIED CAMERA HEAD. THERE WAS NO PATIENT INJURY REPORTED. THIS IS THE REPORT FOR THE FIRST CH-S190-XZ-Q.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610428 HD AUTOCLAVABLE CAMERA HEAD AUTOCLAVABLE CAMERA HEAD FET OLYMPUS MEDICAL SYSTEMS CORP. CH-S190-XZ-Q

    Patients

    Seq Age Sex Outcome Treatment
    1