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 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 described on the literatures.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 november 28th, 2018, olympus medical systems corp.(omsc) received a literature titled ¿the treatment results of the flexible transurethral lithotomy (f-tul) in our hospital¿ that was made in public in the 32th congress of japanese society of endourology.The literature reported that 53 procedures of the f-tul were conducted using olympus ureterorenoscope (urf-v) and a non-olympus ureteral access sheath (12 fr or 14 fr).Between june 2014 and april 2018, the f-tul procedures were conducted after antibiotic administration and microbiological culturing test for the urine sample of the patients.The literatures reported that complications occurred as follows; fever (over 38¿): 4 cases, ureteral injury: 1 case, ureteral perforation: 1 case, renal failure (anuria): 1 case.It was reported that all of the reported complications were not serious injury.Further detailed information such as the relationship between the subject device and all of the reported complications could not been obtained at present.Therefore, according to the number of the type of complications known and the number of device used for procedure, omsc is submitting 4 medical device reports.This is a report on ureteral injury associated with urf-v and two of four 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: 8201719
• MDR Text Key: 131602972
• Report Number: 8010047-2018-02578
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/28/2018

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/27/2018
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other