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

Model Number URF-V

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Urethral Stenosis/Stricture (4501)

Event Date 04/28/2021

Event Type  Injury  

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc) for evaluation.Nonconformity of the subject device, which may affect the reported event, was not confirmed via device inspection result of omsc.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

Olympus medical systems corp.(omsc) was informed from the user that during the removal of ureteral stent with the subject device, the physician could not withdraw the subject device from the patient.The physician noticed that the patient's ureter had convulsed, and the physician administered a muscle relaxant to the patient.The patient's ureter recovered from contraction and the physician completed the procedure.There was no report of the injury other than above.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The exact cause of the reported event could not be conclusively determined.It was confirmed that there was no abnormity of the movement of the angle lever and the angle lever did not freeze while the bending section was angulated.Based on the investigation results, olympus medical systems corp.(omsc) surmised that the subject device could not be removed from the patient since the patient's ureter had convulsed.

• 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: 12201037
• MDR Text Key: 262651801
• Report Number: 8010047-2021-09152
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: URF-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/30/2021
• Initial Date FDA Received: 07/21/2021
• Supplement Dates Manufacturer Received: 08/02/2021
• Supplement Dates FDA Received: 08/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other