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

Model Number	URF-V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fever (1858)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device was not been returned to olympus medical systems corp (omsc).The malfunction of the subject device concerning this case has not been reported.The exact cause could not be determined.
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature titled ¿clinical study of pcnl and urs for kidney stones with a major axis of 20 mm or more¿.The literature reported the result of 31 cases of ureterorenoscopy (urs) between january 2013 and december 2017.There was a possibility that urs was performed using the urf-v.In this literature, it was reported adverse events as follows; ureteral injury: 2 cases.Fever: 4 cases.Fever (septic shock): 1 case.Based on the available information, a direct relationship between the subject device and the reported adverse events could not be determined.Omsc is submitting seven mdrs according to the number of the adverse events.This is 4 of 7 reports.(2 of 4 fever cases).

• Brand Name: URETERO-RENO VIDEOSCOPE
• Common Device Name: 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: 9725584
• Report Number: 8010047-2020-01402
• Device Sequence Number: 2295543
• Product Code: FGB
• UDI-Device Identifier: 04953170287183
• UDI-Public: 04953170287183
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K072957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/19/2020

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
• Operator of Device: Health Professional
• Device Model Number: URF-V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other