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

Model Number CYF-VA2

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device has been returned to olympus for evaluation.In addition to the reportable malfunction mentioned in b5.It was observed, because venting connector of the light guide (lg) connector was shaved, water tightness was lost.Due to wear of the angle wire; bending section could not be controlled.The connecting tube had a dent.Due to damage on the biopsy channel (ch-tube); forceps could not be inserted smoothly.The control unit had corrosion; due to water leakage.The label on the video connector was peeled, the video connector case had a scratch, the electrical contact of video connector was shaved, the video connector, the lg connector, video cable, and the universal cord had a scratch, the universal cord had a dent.Due to damage on the ch-tube; channel cleaning brush could not be inserted smoothly.The up/down (ud) plate, the switch box, and the control unit had a scratch, the video connector case was sticky, and had discoloration, the lg connector had corrosion, the lg-cover glass had corrosion, the video cable was sticky, the universal cord was sticky, the ud plate was sticky, the grip was sticky, the connecting tube had a wrinkle, the grip had a scratch, and the lg bundle was slipping down.The investigation is ongoing.And a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The customer reported to olympus, the visera cysto-nephro videoscope had air/water leakage.Upon inspection of the customer¿s returned device.It was observed, angulation locked; due to angle wire wear.This report is being submitted for the malfunction found during evaluation.There was no harm or user 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.Since the device is more than 15 years old, the device history record was unable to be reviewed.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it¿s likely the angle is locked due to wear and damaged of the angle wire.The final root cause of this event was unable to be identified.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: 16855107
• MDR Text Key: 314501013
• Report Number: 3002808148-2023-04459
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/05/2023

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: 04/13/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/13/2023
• Initial Date FDA Received: 05/02/2023
• Supplement Dates Manufacturer Received: 05/15/2023
• Supplement Dates FDA Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2005
• 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