MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO VIDEOSCOPE

Model Number URF-V2

Device Problem Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/13/2019

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation.Omsc reviewed the manufacturing history of the device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that during an unspecified diagnostic procedure, the user facility noticed that there was an irregularity in the angulation of the subject device and found that the bending section did not work after the withdrawal from the patient.The procedure was completed with another olympus ureterorenoscope (urf-p6).There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device in this report was returned to olympus medical systems corp.(omsc) for evaluation.Omsc took a look at the angle wire that moves the bending section and confirmed that the movement of the angle wire was restricted due to the deformed coil pile that covers the angle wire.It is surmised that the coil pipe was deformed because an excessive compressive force was applied to the angle wire during the angulation operation.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 8427823
• MDR Text Key: 139747645
• Report Number: 8010047-2019-01306
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: K172246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1