MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VIDEOSCOPE "CYF-V2", EUROPEAN VERSION CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-V2

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/24/2019

Event Type  Malfunction  

Manufacturer Narrative

The subject device has not been returned to omsc but was returned to olympus (b)(4). (b)(4) sent the subject device to a third party laboratory for an additional microbiological testing. As a result of the testing, no microbe was detected from the sample collected from the all the channels of the subject device. The testing result cleared the (b)(6) guideline. Omsc reviewed the manufacturing 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, 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 all the channels of the subject device tested positive for staphylococcus lugdunensis (3 cfu / 150 ml) and staphylococcus epidermidis (9 cfu / 150 ml). The testing result does not clear the (b)(6) guideline. The subject device had been reprocessed with a non-olympus automated endoscope reprocessor, soluscope 4, using peracetic acid. There was no report of infection associated with this report.

• Brand Name: VIDEOSCOPE "CYF-V2", EUROPEAN VERSION
• Type of Device: CYSTO-NEPHRO 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: 8397579
• MDR Text Key: 138360648
• Report Number: 8010047-2019-01206
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (Y/N): N
• Reporter Country Code: FR
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: FOREIGN,USER FACILITY
• Reporter Occupation: BIOMEDICAL ENGINEER
• Type of Report: Initial
• Report Date: 03/07/2019

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 03/06/2019
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: CYF-V2
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 02/05/2019
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 01/08/2014
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse