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

Model Number URF-V

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2014

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to omsc for evaluation.The manufacturing history was reviewed, with no irregularities related to this problem noted.Based upon the evaluation of the subject device by omsc it was considered that the distal end of the subject device was not flaking off but being burned by laser.As a result of the evaluation, omsc concluded that the distal end part of the subject device was burned since the user oscillated laser accidentally and/or there was a breakage of the laser probe.Based on the findings, inappropriate handling by the user could not be ruled out as a contributory factor of the event.The instruction manual of urf-v mentions warning and caution for possible mishandling mentioned above, this report is being submitted as a medical device report in an abundance of caution.

Event Description

Olympus medical system corp.(omsc) was informed that the facility found a crack and burned deposit around the biopsy forceps opening of the subject device after the endoscopy.There were no information about when the crack occurred and where the crack portion part fell.There was no patient harm reported.

• 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 moriyaa ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 3969273
• MDR Text Key: 148280595
• Report Number: 8010047-2014-00209
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/04/2014

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: Health Professional
• Device Model Number: URF-V
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/22/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2014
• Initial Date FDA Received: 05/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2008
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1