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

Model Number CYF-VH

Device Problem Break (1069)

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

Event Date 04/20/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was not confirmed as the device evaluation found that the biopsy port was not damaged and noted to be satisfactory for further use.However, inspection found the distal end cap was detached, the light guide plug body eto valve was damaged.Eto valve noted rotating and a leak tester accessory is stuck on it.The up / down angle were not to specification.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus, the cysto-nephro videoscope port of the scope is damaged.The issue was found during reprocessing, the intended cystoscopy was completed with the same device.There were no reports of patient harm.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's 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 root cause of the damage to the port of the scope was incorrect handling of the device.The event can be detected/prevented by following the instructions for use which state: ¿do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.¿ 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: 16967677
• MDR Text Key: 316508985
• Report Number: 3002808148-2023-05069
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411250
• UDI-Public: 04953170411250
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K221683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/27/2023

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-VH
• Device Catalogue Number: N6006040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 05/19/2023
• Supplement Dates Manufacturer Received: 06/01/2023
• Supplement Dates FDA Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2019
• 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