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

Model Number CYF-5

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 02/10/2017

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus medical systems corp.For evaluation.The manufacturing record of the subject device was reviewed with no irregularity relating to the phenomenon.The exact cause of the event could not be concluded at this moment.If additional and significant information becomes available, this report will be supplemented.

Event Description

Olympus was informed that the subject device was tested positive for common flora (6ufc/100ml) when the user facility conducted a routine microbiological test.It is unknown in which part of the scope the microorganisms were found.There was no report of patient infection associated with this report.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation result.The subject device has not been returned to olympus medical systems corp.(omsc) but was returned to olympus (b)(4).The subject device was sent to a third party laboratory for additional microbiological test.In the test, bacilus sp.(1 cfu/100ml) was detected from the biopsy channel of the subject device.The result of the additional microbiological testing by a third party laboratory satisfied the french guideline.

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Type of Device: CYSTONEPHROFIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to ; 426425177
• MDR Report Key: 6562603
• MDR Text Key: 75169466
• Report Number: 8010047-2017-00572
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2017
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1