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

Model Number CYF-VHA

Device Problem Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Event Description

The customer reported to olympus, the cysto-nephro videoscope had air/water leakage.The device was returned for evaluation.During the device evaluation, foreign objects in the objective lens tip were found and foreign body in the illuminated lens at the tip was found.The customer cleaned, disinfected, and sterilized the device before being sent to olympus.There were no abnormalities in the accessories used for reprocessing.It is unknown if the customer wiped/ brushed the distal end with lint-free cloths, brushes, or sponges.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

The device was returned to olympus for evaluation and the evaluation found due to a pinhole on channel tube, water tightness was lost, foreign body in the illuminated lens at the tip was found, control body leakage was found, control body up/ down plate leakage was found, insertion part light-guide bundle leak was found, cable section universal cord leak was found, insufficient curvature tube angle at insertion section was found, collapsed flexible insertion tube was found, rattling of curved tube at the tip was found, and image blurring at the tip was found.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 any additional information is provided by the user facility.

Manufacturer Narrative

This supplemental report is being submitted 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, the foreign material could not be identified.Due to a leak failure due to a channel tube pinhole, proper reprocessing may not have been possible and the foreign matter may not have been removed.However, a definitive root cause for the remaining foreign material could not be established.The event can be detected and prevented by handling the device in accordance with the following sections of the instructions for use: chapter 3 compatible reprocessing methods chapter 4 reprocessing workflow for endoscopes and accessories chapter 5 reprocessing the endoscope (and related reprocessing accessories) chapter 6 reprocessing the accessories chapter 7 reprocessing endoscopes and accessories using an aer/wd olympus will continue to monitor field performance for 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: 18422910
• MDR Text Key: 331670736
• Report Number: 3002808148-2023-14924
• 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
• Report Date: 02/13/2024

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: 12/12/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2017
• 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