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

Model Number CYF-VA2

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 04/18/2019

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to omsc for evaluation but the evaluation is still in progress.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined at this time.If additional information is provided, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that the user facility aborted a therapeutic procedure since the insertion tube is bent and they could not withdraw the subject device from the stenosis in the patient's urethra.The user facility removed the subject device from the patient by cutting the insertion tube of the subject device and inserting a metal rod into the urethra to straighten the bent insertion tube.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The following were confirmed in the evaluation of the omsc.- the insertion tube is cut at about 300 mm from the distal end.- the insertion tube was crushed at about 180 mm to 200 mm from the distal end.- there was no rust and wear on the parts inside the insertion tube (metal wire, metal frame, etc.), and there were no signs of metal fatigue and deterioration.As reported in the initial report, this event occurred when the user facility inserted the subject device into the patient's urethral stricture site and the insertion tube was deformed.The deformation of the insertion tube is likely due to applying an excessive force to the device in order to pass the device through the urethral stricture site.

• 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
• MDR Report Key: 8614784
• MDR Text Key: 145221655
• Report Number: 8010047-2019-01953
• Device Sequence Number: 1
• Product Code: FAJ
• 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: 07/02/2019

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-VA2
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/18/2019
• Initial Date FDA Received: 05/16/2019
• Supplement Dates Manufacturer Received: 06/13/2019
• Supplement Dates FDA Received: 07/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening