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

Model Number URF-V

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated at olympus service operation repair center (sorc).As a result of the evaluation, the following was confirmed.The phenomenon reported by the user could not be confirmed.The watertightness was not maintained due to perforation of the instrument channel due to external factors.The angulation was insufficient due to the elongation of the angle wire.There was a leakage from the light guide bundle, control section, and grip unit due to handling.The watertightness of the rotating mechanism was not maintained.The rotating mechanism, grip unit, universal cord, light guide connector, video cable, video connector, and video connector case were scratched due to external factors.There was a leakage from the up/down plate, universal cord, and light guide connector.It is possible that the liquid came out when the eto cap was removed because the liquid entered the device due to the lack of watertightness due to the perforation of the instrument channel.However, the exact cause of the reported event could not be conclusively determined, because the device has not been returned to omsc.The reported event was not caused by product or manufacturing, and omsc confirmed that there were no issues with device safety.Also, the reported event does not tend to occur frequently.The instruction manual provides precautions for device preparation and inspection.Device history record (dhr) review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed by the user that when the eto cap was removed from the vent connector, something like a liquid came out.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The device was manufactured on (b)(60 2017, and about 4 years and 2 months have passed since the device was manufactured.If additional information becomes available, this report will be supplemented.

• 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: 12311274
• MDR Text Key: 266164239
• Report Number: 8010047-2021-10129
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: K072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Type of Report: Initial,Followup
• Report Date: 09/02/2021

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: Other
• Device Model Number: URF-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/20/2021
• Initial Date FDA Received: 08/12/2021
• Supplement Dates Manufacturer Received: 08/25/2021
• Supplement Dates FDA Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1