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

Model Number URF-P6

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

Patient Problem Fever (1858)

Event Type  Injury  

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 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- p6.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 5 of 7 reports.(3 of 4 fever cases).

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 9725620
• MDR Text Key: 182566167
• Report Number: 8010047-2020-01424
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: URF-P6
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other