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 06/22/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found the following: water dunk test failed; leak from bending section cover or distal sheath rubber; hole at bending section cover or distal sheath rubber; lifting and scratches on bending section cover or distal sheath rubber glue; dent on insertion tube; missing lock pin at the ethylene oxide valve; and detach digital end.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 that the cysto-nephro videoscope had a gap.In addition, the ejection side port was broken.The event occurred during reprocessing and there were no reports of patient or user harm associated with this event.

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, the definitive root cause of the ejection side port damage could not be determined.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: "if the endoscope is dropped or the distal end of the endoscope receives a hard impact, the endoscope may be damaged even if no visible damage of the lens on the distal end can be found.In this case, stop using the endoscope, and contact olympus.Do not twist or bend the bending section with your hands.Equipment damage may result.Do not squeeze the bending section forcefully.The covering of the bending section may stretch or break and cause water leaks.Do not put or press the video connector and light guide connector on the insertion section when transporting or reprocessing.The insertion section may be damaged.Turn the video system center on only when the video connector is connected to the video system center.In particular, confirm that the video system center is off before connecting or disconnecting the video connector.Failure to do so can result in equipment damage, including destruction of the image sensor.The endoscope¿s remote switches cannot be removed from the control section.Pressing, pulling, or twisting them with excessive force can break the switches and/or cause water leaks.Do not hit or bend the electrical contacts on the video connector.The connection to the video system center may be impaired and faulty contact can result." 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: 17365253
• MDR Text Key: 320248382
• Report Number: 3002808148-2023-07317
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170310461
• UDI-Public: 04953170310461
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/01/2023

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/22/2023
• Initial Date FDA Received: 07/20/2023
• Supplement Dates Manufacturer Received: 08/24/2023
• Supplement Dates FDA Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2014
• 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