MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE

Model Number CYF-5

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to omsc but was returned to olympus (b)(4) (ofr).Ofr 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 all channels of the device.The testing result cleared the french guideline.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, following microbes were detected from the sample collected from the subject device.Instrument channel: coagulase-negative staphylococci (29 cfu/endoscope) the device had been manually reprocessed 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 evaluation by an olympus repair center in france confirmed no physical damages of the device.Omsc reviewed the manufacture history (dhr) of the device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.However, it is unlikely that the reported event occurred due to the scope, because no microorganisms were detected during the re-culturing test and no damages were found.

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Type of Device: CYSTONEPHROFIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10864947
• MDR Text Key: 225187042
• Report Number: 8010047-2020-09108
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• PMA/PMN Number: K032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-5
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1