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

Model Number URF-V2

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The subject device has not been returned to olympus medical systems corp (omsc).Omsc could not review the service and manufacturing record because the serial number was not provided from the facility.There was no malfunction report of the subject device concerning the events.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

On september 27, 2018, olympus medical systems corp.(omsc) received a literature titled ¿clinical study on f-tul treatment outcome for kidney stones in our hospital¿.Complications after f-tul (flexible transurethral lithotomy) using olympus uretero-reno videoscope (urf-v or urf-v2) were reported in the literature.The literature reported that 56 cases of f-tul procedures using the subject device were conducted between april 2010 and march 2017.In the procedures, 9 cases of complications reportedly occurred as follows: acute pyelitis: 3 cases.Stone street: 5 cases.Ureteral stenosis : 1 case.The literature concluded that f-tul is safe and effective treatment.There was no information on which model of the endoscope was used in each procedure.Further detailed information could not been obtained at present.According to the number of the type of complication (acute pyelitis, stone street, and ureteral stenosis), omsc is submitting 3 medical device reports for each endoscope model (total 6 of mdrs).This is a report on stone street in urf-v2 and 6 of 6 reports.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 7983251
• MDR Text Key: 124330755
• Report Number: 8010047-2018-02034
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: URF-V2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2018
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other