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

Model Number URF-V2

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation.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 from the user that during the unspecified timing, the angle wire of the subject device was broken.Olympus (b)(4) checked the subject device and found that the reported phenomenon was duplicated and the bending section remained angulated due to the broken angle wire.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 was not returned to olympus medical systems corp.(omsc) for evaluation, but was returned to olympus south korea (okr).Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Okr evaluated the device and confirmed that the angulation of the bending section of the device was abnormally curved.The exact cause of the reported phenomenon could not be conclusively determined.Based upon the past similar case, the reported phenomenon could have occurred, as the angulation wire which manipulates the bending section was stuck due to the internal metal parts deformed by angulating the bending section while the bending section been fixed.

• 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 192-8 507; JA 192-8507
• MDR Report Key: 10933686
• MDR Text Key: 219527233
• Report Number: 8010047-2020-09706
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1