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 broken insertion tube, perforated instrument channel, and broken video cable.The angulation was insufficient due to the stretch of the angle wire.There was a leakage from the light guide bundle, grip unit, up/down plate, and universal cord.The insertion tube was crushed due to external factors.The control section was corroded by a leakage.The adhesive of the bending section rubber was chipped.The remote switch 1 was malfunctioning.The grip unit, universal cord, angulation control lever, light guide connector, video connector case, and up/down angulation lock were scratched due to external factors.The exact cause of the reported event could not be conclusively determined.However, the coating may have peeled off due to some external force applied to the insertion tube.The reported event was not attributed to the product or manufacturing, and olympus medical systems corp.(omsc) confirmed that there were no issues with device safety.Also, the reported event does not tend to occur frequently.Omsc checked the repair history and confirmed that the device was repaired on may 20, 2020.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

The user returned the device to olympus because the coating of the insertion section was peeled off.Olympus then inspected the device at olympus service operation repair center (sorc) and found that the coating of 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: 12750232
• MDR Text Key: 284811776
• Report Number: 8010047-2021-14047
• 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
• Type of Report: Initial
• Report Date: 11/04/2021

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: 10/07/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/08/2021
• Initial Date FDA Received: 11/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1