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

Model Number CYF-V2

Device Problems Failure to Advance (2524); Material Deformation (2976)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Event Description

The customer reported to olympus, during a diagnostic cystoscopy the tip of the scope curled into a knot and was stuck in the urethra.It is unknown if the device was inspected prior to the procedure.The physician was getting resistance when she was feeding the tip of the scope through the urethra and then realized it was stuck.The physician was unable to view what was going on at that time.The physician did not pull the scope out and took the patient to the operating room.While in the operating room, the physician was able to use fluoroscopy to visualize the scope.The physician proceeded to make a small incision in the bladder and pull the scope into the bladder to untie it and remove it through the urethra.The scope had tied around on itself.The intended procedure was not completed.The patients care was delayed since he required a catheter and a radiological procedure afterwards.The intended procedure has not been rescheduled to date.

• 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: 14112144
• MDR Text Key: 289314731
• Report Number: 2951238-2022-00378
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339431
• UDI-Public: 04953170339431
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2022,04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-V2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/21/2022
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/21/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Race: White