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

Model Number CYF-V2

Device Problems Break (1069); Device Reprocessing Problem (1091)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was received by olympus evaluation.The user facility report was confirmed and found leaking at a rubber glue and damage on the scope.Additional information provided by the reporter on (b)(6) 2020 confirmed that the sterile processing team at the facility did not put the valve back on the scope during reprocessing which may have led to the defect of the scope.The device has been serviced and returned to the user facility.Olympus will continue to monitor complaints for this device.

Event Description

The user facility reported that the distal end of the scope is broken.Additional information provided by the reporter on august, 7 2020 confirmed that the sterile processing team at the facility did not put the valve back on the scope during reprocessing which may have led to the defect of the scope.The reporter indicated that corrective actions have been taken on site with training to ensure this doesn't happen in the future.No additional information was provided.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 10381354
• MDR Text Key: 202187008
• Report Number: 8010047-2020-05388
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411199
• UDI-Public: 04953170411199
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/07/2020

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: Other
• Device Model Number: CYF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 08/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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