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 Known Impact Or Consequence To Patient (2692)

Event Date 08/10/2018

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report has not yet been returned to omsc for evaluation.Omsc reviewed the manufacture history of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available or if the device is returned at a later time, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that as a result of microbiological testing by the user facility, the sample collected from the subject device tested positive for staphylococcus hominis (1cfu) and staphylococcus epidermidis (1cfu).The facility sterilized the subject device with a non-olympus sterilizer, sterrad nx100.There was no report of infection associated with this report.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.It was found that as a result of additional microbiological testing by the user facility, the sample collected from the subject device tested positive for corynebacterium freneyi (1cfu).The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

• 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
• MDR Report Key: 7849956
• MDR Text Key: 119655258
• Report Number: 8010047-2018-01719
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: K072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: URF-V2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1