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

Model Number	CYF-V2R
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and service.The evaluation confirmed that the device failed the leak test.Based on the visual inspection performed, the bending section cover was found torn at the middle section; no missing pieces.The distal end portion of the bending section was stretched over the tip.The large torn on the bending section cover caused the device to failed the air/water leakage test.The device was serviced and returned to the user facility.
Event or Problem Description
The user facility returned the device for evaluation and service due to the air/water leakage or fluid invasion issue.It was also reported that the bending section sheath of the bending section burst out, as the device was sterilized without attaching the safety cap.Olympus followed up with the user facility to obtain additional information and was informed that there was no patient involvement.No additional information was provided.
Event or Problem Description
Upon further review, this is not a reportable malfunction.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.
Additional Manufacturer Narrative
Upon further review, this is not a reportable malfunction.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: VISERA CYSTO-NEPHRO VIDEOSCOPE
• Common Device Name: 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: 10153099
• Report Number: 8010047-2020-03338
• Device Sequence Number: 2042732
• Product Code: FAJ
• UDI-Device Identifier: 04953170287619
• UDI-Public: 04953170287619
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K133538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2020

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
• Operator of Device: Health Professional
• Device Model Number: CYF-V2R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 06/15/2020
• Supplement Report FDA Received Date: 06/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1