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

Model Number CYF-V2

Device Problem Difficult to Remove (1528)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has been received by olympus, but has not yet been fully evaluated.The definitive cause of the customer's experience can not be determined at this time.This report will be updated upon completion of the investigation and if any relevant additional information is available.

Event Description

It is reported during a diagnostic cystoscopy using topical anesthetic (lidocaine gel) and a visera cysto-nephro videoscope, at the end of the procedure, the angulation on the scope became locked and would not disengage/straighten out and was stuck in the patient's urethra.The scope retroflexed at 180 degrees.There was urethral dilation that caused minor bleeding/mucosal tears requiring no treatment.There was no delay in the procedure and the planned procedure was completed using the complaint device.No additional consequences to the patient were reported.The scope was inspected prior to use and no damage or abnormalities were noted.

Manufacturer Narrative

The report is being updated to provide investigation findings.New information is reported in h6 and h10.A review of the device history record (dhr) was conducted and it concluded there were no abnormalities in manufacturing.Conclusion: the definitive root cause could not be identified.Based on the investigation results, the probable causes could be related to improper user¿s handling causing the insertion tube to become stuck in the patient¿s body (in urethra) by the causing failure to straighten the bending section; or a malfunction in the up/down angulation control lever might have caused failure.In addition, forcible angle control could have caused malfunction in the angulation control.Lastly, service records indication it has been 9 (nine) years and five months since the actual device was manufactured on june 6 2011.It is determined the indication phenomenon was caused by age deterioration as well.

• 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: 10825092
• MDR Text Key: 224686833
• Report Number: 8010047-2020-08794
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411199
• UDI-Public: 04953170411199
• Combination Product (y/n): N
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/11/2021

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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 12/16/2020
• Supplement Dates FDA Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 82