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

Model Number URF-V

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2019

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation. 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.

Event Description

Olympus medical systems corp. (omsc) was informed that as a result of routine microbiological testing by the user facility, the sample collected from the instrument channel of the subject device tested positive for the following microbes. Klebsiella pneumoniae. Escherichia coli. Enterococcus faecalis. Staphylococcus aureus. Providencia rettgeri. Myroides sp. The total number of these microbes is >100 cfu/ml. The device had been reprocessed with an olympus automated endoscope reprocessor model etd4 (not available in the usa) using peracetic acid. There was no report of infection associated with this report.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information. The subject device has not been returned to omsc but was returned to olympus europa (b)(4). (b)(4) investigated the subject device and found that there was no malfunction. (b)(4) (b)(4) sent the device to a third party laboratory for microbiological testing. As a result of the testing, no microbe was detected from the sample collected from the distal end and the instrument channel of the device. The exact cause of the reported event could not be conclusively determined. 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 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 9258338
• MDR Text Key: 219774239
• Report Number: 8010047-2019-03762
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/25/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: URF-V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 11/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse