MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VIDEOSCOPE "CYF-V2", UK VERSION; FLEXIBLE VIDEO CYSTONEPHROSCOPE

Model Number CYF-V2

Device Problem Peeled/Delaminated (1454)

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

Event Date 06/13/2022

Event Type  malfunction  

Event Description

The customer reported that the outside layer was coming off the working channel of the subject device.The issue was observed when they were preparing the device for use.There was no patient or user injury reported due to the event.Additional details were requested regarding the reported event.At this time, no additional information has been provided.

Manufacturer Narrative

The subject device was returned to an olympus service center for evaluation.During inspection and testing, service found the outer covering of the insertion tube was peeling off.In addition, the image was observed to be flickering.The labels were found worn and peeling.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Manufacturer Narrative

This report is being submitted to provide the results of the legal manufacturer's investigation not included on the previous report.A review of the device history record found no deviations, that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.The investigation results could not determine, the specific root cause at this time.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This supplemental report is to inform that upon further review, this is not a reportable malfunction.The legal manufacturer's investigation found, that there was no foreign material coming off the working channel, only the metal was exposed.The metal exposure from the serpentine at the insertion section may have occurred, due to stress or handling or other factors.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• Brand Name: VIDEOSCOPE "CYF-V2", UK VERSION
• Type of Device: FLEXIBLE VIDEO CYSTONEPHROSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14999825
• MDR Text Key: 295778498
• Report Number: 8010047-2022-11814
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• 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: 06/20/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2020
• 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