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 was 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.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 title "steep infundibulopelvic angle as a new risk factor for flexible ureteroscope damage and complicated postoperative course." the literature reported the result of 381 cases of the flexible ureteroscopy (furs) procedures using an olympus model urf-v (ureteroscope) and fb-56d-1 (biopsy forceps) between september 2013 and march 2017.In the subject procedures, the following cases reportedly occurred.4 bleeding complication cases.27 urinary tract infection cases.5 perforation cases of the upper urinary tract.2 pneumonia cases.2 unknown complications.Based on the available information, a direct relationship between the subject devices and the observed reported adverse events could not be determined.According to the number of accidental symptoms and the number of olympus devices used for the procedures, omsc is submitting 10 medical device reports.This is the 10th of 10 reports for perforation of the upper urinary tract and urf-v.

• 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: 9726308
• MDR Text Key: 192681980
• Report Number: 8010047-2020-01446
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,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: No Information
• Device Model Number: URF-V
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2020
• 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: N
• Patient Sequence Number: 1