MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-VH

Device Problems Defective Component (2292); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 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.

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 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: CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• 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
• MDR Text Key: 332731788
• Report Number: 3002808148-2024-00153
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K221683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: CYF-VH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 01/05/2024
• Supplement Dates Manufacturer Received: 04/03/2024
• Supplement Dates FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1