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

Model Number CYF-VA2

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 05/17/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.During the evaluation, the customer's original reported issue of brown liquid dripping from the channel was not confirmed.The following additional findings were also noted: damaged switch button number two, damaged switch button number three due to breakage of the switch board, pinhole on the channel tube and connecting tube causing water tightness to be lost, dent on the connecting tube and universal cord, sticky up/down angulation lever plate and universal cord, shaved electrical contact of the video connector, assorted discolorations, wear on switch button one and four, sticky control unit due to water leakage, bending angle in the up direction does not meet standard value, channel cleaning brush cannot insert smoothly due to a dent on the channel tube and the light guide bundle was slipping down.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

A customer reported to olympus that brown liquid drips from the channel of visera cysto-nephro videoscope and buttons on the videoscope do not work.The scope was washed twice, and brown liquid drips were still present.Customer indicated the scope was not inspected prior to use.The procedure was completed and there was no reports of patient or user harm associated with this event.

Event Description

Additional information: the issue was observed during cleaning at the time of vendor inspection.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Updated fields: the following fields were corrected based on information available at the time of the initial report submission: a review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 13 years since the subject device was manufactured.Based on the results of the investigation, it is likely that the reprocessing could not be completed due to the leak failure caused by the forceps channel pinhole, and the foreign matter came out.However, a definitive root cause could not be established.The event can be detected and prevented by handling the device in accordance with the following sections of the instructions for use: ·chapter 6 application and conditions of cleaning, disinfection and sterilization ·chapter 7 cleaning, disinfection and sterilization procedures olympus will continue to monitor field performance for this device.

• Brand Name: VISERA 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: 17171325
• MDR Text Key: 318121724
• Report Number: 3002808148-2023-06211
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339455
• UDI-Public: 04953170339455
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Non-Healthcare 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-VA2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/22/2023
• Initial Date FDA Received: 06/21/2023
• Supplement Dates Manufacturer Received: 06/23/2023
• Supplement Dates FDA Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2010
• 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
• Treatment: LIGHT SOURCE CLV-S40PRO; VIDEO SYSTEM OTV-7PRO