MAUDE Adverse Event Report: NAGANO OLYMPUS CO., LTD. ZOOM MICROSCOPE BODY; COLPOSCOPE

Model Number	OCS5-ZB
Medical Device Problem Codes	Defective Component (2292); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the device has not been returned to olympus for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if additional information becomes available.
Event or Problem Description
The customer reported to olympus that the cysto-nephro videoscope had a broken head, damaged lenses, and optics.There were no reports of patient harm.
Additional Manufacturer Narrative
Correction to g3 of the initial report, the date the "date received by the manufacture" was 15mar2024.Correction to h6 "medical device problem code" from "2292 - defective component" to "2907 - detachment of device or device component".The facility registration is 3009561595.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Despite good faith attempts additional information was not made available to olympus.The subject device was evaluated where the reportable malfunction noted in b5 was confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely that use and handling over time caused the event.Olympus will continue to monitor field performance for this device.
Event or Problem Description
Correction to b5 of the initial report.On 07mar2022 the user facility noted non-reportable malfunctions of a broken head, damaged lenses and optics.It is unknown if the issue occurred on that date or earlier.An incorrect model number was communicated to olympus and the user facility could not communicate the correct model number.On 12feb2024 the subject device (a zoom microscope body) with the same serial number was evaluated where a reportable malfunction of breakage of the colposcope was noted where the zoom microscope body was disconnected from the balance arm.There were no reports of patient harm.This report is being submitted for the reportable malfunction noted during the device evaluation.

• Brand Name: ZOOM MICROSCOPE BODY
• Common Device Name: COLPOSCOPE
• Manufacturer (Section D): NAGANO OLYMPUS CO., LTD.; 6666 inatomi; tatsuno-machi,; kamiina-gun, nagano 399-0 495; JA 399-0495
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 6666 inatomi; tatsuno-machi,; kamiina-gun, nagano 399-0 495; JA 399-0495
• Manufacturer Contact: masaharu hirose ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18451623
• Report Number: 3002808148-2024-00153
• Device Sequence Number: 17867721
• Product Code: HEX
• UDI-Device Identifier: 04953170331763
• UDI-Public: 04953170331763
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K221683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: OCS5-ZB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2004
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown