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

Model Number URF-P5

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

Patient Problems Inflammation (1932); Injury (2348)

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 tul treatment outcome for kidney stones and ureteral stone in our hospital¿.The literature reported the result of tul (transurethral lithotomy) procedures using olympus uretero-reno videoscope (urf-p5) with an non olympus ho:yag laser for 70 cases at the user facility between january 2017 and january 2018.In the subject procedures, acute pyelonephritis (2 cases) and intraoperative ureteral injury (2 cases) occurred.There was no reported of malfunction on the subject device.Further detailed information could not been obtained at present.Therefore, according to the number of the type of complication (acute pyelonephritis and intraoperative ureteral injury), omsc is submitting 2 medical device reports for each endoscope model.This is a report on acute pyelonephritis.(1 of 2 reports).

• Brand Name: OES 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: 8007876
• MDR Text Key: 125105284
• Report Number: 8010047-2018-02053
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: URF-P5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2011
• 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