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

Model Number URF-V

Device Problems Leak/Splash (1354); Mechanical Problem (1384); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2015

Event Type  malfunction  

Event Description

Olympus medical system corp.(omsc) was informed that during the pnl procedure, a stone was at the front of the subject device, but the user facility could not perform angulation control and retrieved the subject device from the patient.The intended procedure was completed with a backup instrument.The user felt like a wire snapped, before the angulation control became disabled.There was no patient harm reported.

Manufacturer Narrative

The subject device was returned to omsc for evaluation.Based upon the evaluation of the subject by omsc, the phenomenon duplicated and the angulation control did not operate in the down side.The leakage test was performed and the subject device failed due to pinholes at the opening of the instrument channel and the bending cover.Furthermore, inside the pinhole of bending cover, it was confirmed that the angulation wire was broken and burned.The light guide bundle and a part of bending structure close to the wire breakage point had melting marks.The manufacturing history was reviewed with no irregularities related to this problem noted.Based on the findings, this event possibly derived from the user's improper handling such as activating laser emission with out the edge of a laser probe sticking out of the subject device.

• 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: susumu nishina ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 26425177
• MDR Report Key: 4926205
• MDR Text Key: 16954148
• Report Number: 8010047-2015-00597
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/26/2015

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: Health Professional
• Device Model Number: URF-V
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/10/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2015
• Initial Date FDA Received: 07/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1