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

Model Number URF-V

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated at sorc.As a result of the evaluation, the following was confirmed.-the watertightness was not maintained due to the tearing of the insertion tube due to external factors.-external factors damaged the grip unit, angulation control lever, universal cord, video connector, light guide connector, video connector, and up/down angulation lock.-the universal code was wrinkled.The coating on the insertion tube may have peeled off due to some external force applied to the insertion tube.However, the exact cause of the reported event could not be conclusively determined, because the device has not been returned to olympus medical systems corp.(omsc).The reported event was not attributed to the product or manufacturing, and omsc confirmed that there were no issues with device safety.Also, the reported event does not tend to occur frequently.From the device repair history, omsc confirmed that the bending section rubber, bending section, boot and rotating mechanism were replaced on (b)(6), 2021 and the insertion tube was replaced on (b)(6), 2019.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 inspected the device at olympus service operation repair center (sorc) and found that the coating on the insertion tube was peeled off by more than 4 mm at maximum width.There was no report of patient injury associated with the event.

• 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: 12558942
• MDR Text Key: 281393224
• Report Number: 8010047-2021-12535
• 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: company representative,distri
• Type of Report: Initial
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• 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: 09/07/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1