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 device was not returned to olympus medical systems corp.(omsc), but returned to the department of olympus (b)(4) for the evaluation.The exact cause of the reported event could not be conclusively determined at this time.If significant additional information is received, this report will be supplemented.

Event Description

A customer reported that the device did not flex during preparation for use.The device was sent to an external agency named melba and it was found that angulation of the bending section of the device was locked and could not be disengaged.Olympus (b)(4).Inspected the device and found that there was a leak from the bending section.The metal part in the bending section was not exposed but was crushed and distorted.The bending section could not be moved.There was no report of patient injury associated with this event.

Manufacturer Narrative

Based on the following, olympus re-evaluated the events that occurred on this device and determined that these failure modes were not mdr reportable malfunctions.Therefore, this report is being submitted to retract the mdr on the event.Further inspection of the device by olympus italia s.R.L.Confirmed followings: the cable support in the bending section was disconnected.The bending section was damaged.The first check blocked the movement of the bending section, but it was released by epeating the maneuver.Based on these results, olympus medical systems corp.(omsc) determined that it was possible to unlock the bending section, although it did not bend / return smoothly.

• 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: 11062794
• MDR Text Key: 227217116
• Report Number: 8010047-2020-10864
• 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,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 02/15/2021

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: URF-V2
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 01/22/2021
• Supplement Dates FDA Received: 02/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1