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

Model Number URF-V2

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/06/2016

Event Type  malfunction  

Manufacturer Narrative

The manufacturing record of the two subject devices was reviewed without irregularity.As a result of culture conducted on the two subject devices by olympus (b)(6) s.A.S (ofr), bacteria was not detected.Ofr sent the test result and the two subject device to the user facility.The exact cause could not be determined at present.Omsc is following up with the user facility to obtain additional information regarding the reported event.If significant additional information is received at a later time, a supplemental report will be followed.

Event Description

Olympus medical system corp.(omsc) was informed that the facility performed a culture test, and bacteria was detected from unused two urf-v2s.There was no patient infection reported on this event.This report is 2 of 2.

• 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: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 8142642517
• MDR Report Key: 6134357
• MDR Text Key: 61439272
• Report Number: 8010047-2016-10080
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PK072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/25/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1