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

Model Number CYF-VHA

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Type  malfunction  

Event Description

The customer reported to olympus, there was an e311 error (the white balance has not been set).During the inspection and testing of the returned device, there was a foreign object in the illumination lens.There were no reports of patient harm associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during the device evaluation.

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer¿s allegation was not confirmed.In addition to the findings reported in event, scratches were found throughout the device, wrinkles were found in the insertion tube, the bending angle was insufficient due to elongation of the angle wire, the light guide bundle was burning, there was play on the curved pipe and the universal cord was collapsed.There was yellowing observed and the image was dark to due the burning of the light guide bundle.Additional information has been requested regarding this event.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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, and from the burn-like state of the illumination lens, it is likely that the foreign matter could not be removed even after proper reprocessing due to physical damage to the illumination lens.A definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.

• 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.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16019625
• MDR Text Key: 308235918
• Report Number: 3002808148-2022-05445
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2023

1 Device was Involved in the Event

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-VHA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2022
• Initial Date FDA Received: 12/20/2022
• Supplement Dates Manufacturer Received: 12/22/2022
• Supplement Dates FDA Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2015
• 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