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

Model Number CYF-VHR

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 02/05/2024

Event Type  malfunction  

Event Description

It was reported, there is a cut in the light cable rubber and the bending rubber is broken of the videoscope.The issue occurred during reprocessing.There were no reports of patient harm.

Manufacturer Narrative

The device was returned and the evaluation found a leak at the light guide lens and insertion tube due to cuts.Should additional relevant information become available, a supplemental report will be submitted.

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.It has been over 10 years, since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be established.The suggested phenomenon was confirmed.However, it could not be further identified, nor presumed from the information obtained for this investigation.As a result of confirming, contents of the instruction manual, the following description was identified, which may have been relevant to the prevention of the suggested phenomenon: do not strike, hit or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, video connector or light guide connector.Also, do not bend, pull or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, video connector or light guide 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: 18785692
• MDR Text Key: 337084037
• Report Number: 3002808148-2024-01799
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170310522
• UDI-Public: 04953170310522
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

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: Other
• Device Model Number: CYF-VHR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: 03/11/2024
• Supplement Dates FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2014
• 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