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

Model Number URF-V2

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/17/2019

Event Type  malfunction  

Manufacturer Narrative

The device was returned to omsc for evaluation.The evaluation is in progress.Omsc reviewed the manufacturing history of the device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that the user facility noticed the bending section rubber of the subject device had been broken after a transurethral ureterolithotripsy procedure.It is unknown exactly when the reported phenomenon occurred, but the user facility believes that it occurred during the procedure.The user facility is concerned that a part of the broken bending section rubber fell off and remains in the patient body, but it was not confirmed.There was no patient injury associated with this report.

Manufacturer Narrative

This supplemental report is being submitted to provide the evaluation result for the subject device.The device was returned to olympus medical systems corp.(omsc) for evaluation.The evaluation confirmed that the bending section rubber of the device was torn and partially missing.Furthermore, it was confirmed that the bending tube was broken.The cause of the torn bending section rubber might be due to contact with a sharp object.The cause of the broken bending section is likely due to stress such as torsion because diagonal cracks were noted.

• 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
• MDR Report Key: 8626935
• MDR Text Key: 145933978
• Report Number: 8010047-2019-01981
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: URF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1