MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-V2

Device Problem Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The referenced scope was returned to the service center but the evaluation is in process.The scope was purchased on november 23, 2019 with no previous repair records.The investigation is ongoing; therefore, the root cause of the reported malfunction cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.

Event Description

The service center was informed that during an unspecified event, the customer reported black material was coming out of distal end of the visera cysto-nephro videoscope.No patient injury or harm was reported.

Manufacturer Narrative

The evaluation found the scope was leaking from the instrument channel.No other abnormalities were noted.The scope was repaired and returned to the customer.As part of the investigation, olympus followed up with the user facility to obtain additional information but with no results the legal manufacturer performed the device history records for this device; no abnormalities were found.The investigation was completed and the legal manufacturer determined that there is no manufacturing, material or processing related cause for this failure mode.The likely cause of the reported event was due to the following: foreign matter that could not be removed due to insufficient cleaning of the subject product came out during cleaning.A pinhole was generated in the instrument channel, and molykote in the insertion tube came out.However, because the product cannot be checked, the root cause was not identified.Olympus will continue to monitor complaints for this device.

• Brand Name: VISERA CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11164280
• MDR Text Key: 227895855
• Report Number: 8010047-2021-01330
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339431
• UDI-Public: 04953170339431
• Combination Product (y/n): N
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CYF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1