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

Model Number CYF-VHA

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

It was observed that during device evaluation, the videoscope had the tip edge detach.There were no reports of patient harm.

Manufacturer Narrative

The device evaluation is ongoing.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 and device evaluation.The device was evaluated by olympus.During device evaluation it was discovered that the tip edge has been removed (falling of the component part of the tip (including the bending section cover).Additionally, there were non-reportable (non-pae) defects noted.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 phenomenon "tip edge has been removed(falling of the component part of the tip (including the bending section cover))." could not be identified with the information received.The event can be prevented by following the instructions for use which state: -bladder and renal pelvis video scope -olympus cyf-vha -for safe use "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 may be damaged and could cause patient injury in the body cavity, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient." "do not apply shock to the distal end of the insertion section, particularly the objective lens surface at the distal end.Visual abnormalities may result." "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." 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: 19130149
• MDR Text Key: 341464666
• Report Number: 3002808148-2024-03592
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411274
• UDI-Public: 04953170411274
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/13/2024

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: Other
• Device Model Number: CYF-VHA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/10/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 05/10/2024
• Supplement Dates FDA Received: 05/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2011
• 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