MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VIDEOSCOPE "URF-V"; URETERO-RENO VIDEOSCOPE

Model Number URF-V

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

Patient Problem Perforation (2001)

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.Since the serial number is unknown, the device history record could not be reviewed.However, omsc has only shipped devices that passed the inspection.In the literature, there is no description of the device's malfunction.

Event Description

On january 14, 2021, olympus medical systems corp.(omsc) received the literature titled "clinical review of tul cases at our hospital".This study was conducted on the transurethral ureterolithotripsy (tul) for 69 patients with urinary stones between april 2016 to september 2019.In the literature, it was reported that 14 patients of ureter mucosal damage including 4 patients who had developed perforation, and 6 patients of pyelonephritis including 2 patients who had developed sepsis.Based on the available information, the ureter mucosal damage and the pyelonephritis were not reported in a direct relationship with the olympus products.However, omsc assumes that these events might be related to the subject device since the subject device was used for tul.Especially, omsc presumes that the developed perforation and the developed sepsis were reportable events due to more severe than the ureter mucosal damage and the pyelonephritis.There is no description of the device's malfunction.Omsc will submit two medical device reports (mdr) of the subject device for perforation and sepsis.This is a report regarding perforation.

• Brand Name: VIDEOSCOPE "URF-V"
• 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: 11228341
• MDR Text Key: 231127082
• Report Number: 8010047-2021-01874
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2021

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: No Information
• Device Model Number: URF-V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 01/26/2021
• 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