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

Model Number CYF-VHA

Device Problems Corroded (1131); Mechanical Problem (1384)

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

Event Date 12/15/2022

Event Type  malfunction  

Event Description

The customer returned a cysto-nephro videoscope because the angulation control level was not functioning as intended.Upon inspection and testing of the returned device, it was noted that the bending section could not be controlled due to corrosion of the angle mechanism.There were no reports of patient harm associated with the event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

The device was returned for evaluation.It was noted that water tightness was lost due to damage to the instrument channel.The adhesive on the bending section rubber was worn.It was also noted that the water supply connector was deformed and the image had white dots due to damage to the charge coupled device.The control unit had corrosion due to water leakage.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.

Event Description

Additional information was received from the customer which confirmed the reported event occurred during preparation for use of an unknown diagnostic procedure.There was no delay to the procedure and the procedure was completed using a similar device.There was no patient harm or consequence reported as a result of the event.

Manufacturer Narrative

This report is being supplemented to provide additional information obtained from the customer.

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, a definitive root cause of the reported ¿inability to operate the bend¿ issue could not be determined, however, it is likely that during user handling, the device leaked and water entered the device, causing the angle mechanism to corrode and render the flexure inoperable.In addition, since the angle measurement was possible, the angle lock was not performed.The event may be detected/prevented by following the instructions for use which state: ¿ inspection of the bending mechanism¿.¿perform a leakage test on the endoscope after each precleaning procedure.Do not use the endoscope if a leak is detected.Use of an endoscope with a leak may cause a sudden loss of the endoscopic image, damage to the bending mechanism, or other malfunctions.Use of a leaking endoscope may also pose an infection control risk¿.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: 16198741
• MDR Text Key: 309134478
• Report Number: 3002808148-2023-00548
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170310508
• UDI-Public: 04953170310508
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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,Followup
• Report Date: 07/07/2023

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: 12/19/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/19/2022
• Initial Date FDA Received: 01/18/2023
• Supplement Dates Manufacturer Received: 05/08/2023; 06/30/2023
• Supplement Dates FDA Received: 05/26/2023; 07/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2017
• 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