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

Model Number URF-V

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2014

Event Type  malfunction  

Event Description

Olympus medical system corp.(omsc) was informed that during f-tul procedure, it became difficult to observe since the monitor screen got darkened.Therefore, the user facility replaces urf-v with urf-v3 and continued the procedure.The subject treatment was completed.There was no patient harm reported.

Manufacturer Narrative

The subject device was returned to omsc for evaluation.But the reported phenomenon was impossible to duplicate event after electric current was applied for thirty minutes.Evaluation confirmed a tear of bending rubber at distal, down-right side, deformation of bending section, insufficient bending angle and not smooth actuation of angle lever.In addition, dents and wrinkles were confirmed, but they did not become into a hole.Furthermore, light intensity was deficient slightly compared with the standard.Based on the findings, temporary failure of electric component such as video-connector caused by immersion from the tear of bending rubber could not be ruled out as a contributory factor of the event.The manufacturing history was reviewed, with no irregularities related to this problem noted.This report is being submitted as a medical device report in an abundance of caution.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hachioji-shi; tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi; tokyo 192-8-507 ; JA 192-8507 ; 26425177
• MDR Report Key: 4284080
• MDR Text Key: 5228670
• Report Number: 8010047-2014-00546
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: URF-V
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/11/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/03/2014
• Initial Date FDA Received: 10/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1