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

Model Number CYF-VH

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 05/19/2023

Event Type  malfunction  

Manufacturer Narrative

At this time, it has been indicated to olympus that the device will not be returned for testing and evaluation.Should additional information become available, or the evaluation is completed, a follow-up report will be submitted.

Event Description

The customer reported to olympus the cysto-nephro videoscope had black fluid leaking from the scope.Despite our attempts, we were unable to obtain further information regarding this event.There was no patient/user harm or injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information, based on the legal manufacturer's final investigation and correction to g2, h3.The g2 field was corrected, based on information available at the initial report submission.H3 was also corrected.And "no" had not been selected.The device history record was unable to be reviewed for this device, since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.A root cause could not be established, as the product was not received for a physical evaluation.The event can be detected and prevented by handling the device in accordance with the following sections of the instructions for use: chapter 4: reprocessing workflow for endoscopes and accessories; chapter 5: reprocessing the endoscope.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: 17135581
• MDR Text Key: 317925305
• Report Number: 3002808148-2023-06005
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/19/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/19/2023
• Initial Date FDA Received: 06/15/2023
• Supplement Dates Manufacturer Received: 06/23/2023
• Supplement Dates FDA Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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