MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. VIDEOSCOPE "CYF-V2", UK VERSION; FLEXIBLE VIDEO CYSTONEPHROSCOPE

Model Number CYF-V2

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 08/15/2022

Event Type  malfunction  

Manufacturer Narrative

The suspect device was sent to an olympus service center for evaluation.Inspection and testing found there was a tear on the insertion tube due to cuts and scratches caused by contact with something sharp from the outside and the insertion tube was leaking and taped.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

The customer reported that, during preparation for use, a tear was observed in the out channel of the subject device.There was no harm or user injury reported due to the event.Additional details have been requested regarding the reported event.At this time, no additional information has been provided.

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.Approximately 2 years have passed since the device was manufactured.Based on the results of the legal manufacturer's investigation, since no damage was confirmed, we were unable to determine what caused the damage to the forceps port that pointed out.A definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.

• Brand Name: VIDEOSCOPE "CYF-V2", UK VERSION
• Type of Device: FLEXIBLE VIDEO CYSTONEPHROSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15416939
• MDR Text Key: 306412098
• Report Number: 3002808148-2022-01986
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170339431
• UDI-Public: 04953170339431
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2022

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-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/15/2022
• Initial Date FDA Received: 09/14/2022
• Supplement Dates Manufacturer Received: 10/31/2022
• Supplement Dates FDA Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2020
• 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