MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. FIBERSCOPE "CYF-5", EUROPEAN VERSION; CYSTONEPHROFIBERSCOPE

Model Number CYF-5

Device Problem Microbial Contamination of Device (2303)

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

Event Date 06/11/2019

Event Type  malfunction  

Manufacturer Narrative

The subject device had 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 testing.In the result of the additional microbiological testing, the subject device tested positive for staphylococcus coagulase negative(1 cfu/endoscope).The physical findings of the subject device were not reported.Omsc reviewed the manufacturing history(dhr) 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 is received, this report will be supplemented.

Event Description

Olympus was informed that as a result of microbiological testing by the user facility, the subject device repeatedly tested positive for the following bacteria.On (b)(6) 2019: the biopsy channel: unspecified bacteria(50 cfu/100ml).On (b)(6) 2019: the biopsy channel: unspecified bacteria(40 cfu/100ml).The subject device had been brushed manually using a non-olympus cleaning brush(prince medical, kit 1 clean: diametre 1.8) and disinfected using non-olympus automated endoscope reprocessor (getinge, poka-yoke) with peracetic acid.After reprocessing, the subject device was stored in the storage cabinet(olympus).There was no report of patient infection associated with this report.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The result of the additional microbiological testing didn't clear the (b)(6) guideline.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

• Brand Name: FIBERSCOPE "CYF-5", EUROPEAN VERSION
• Type of Device: CYSTONEPHROFIBERSCOPE
• 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: 8810159
• MDR Text Key: 207925695
• Report Number: 8010047-2019-02607
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2019
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1