MAUDE Adverse Event Report: OLYMPUS TOKIO FIBERSCOPE "CYF-5", EUROPEAN VERSION

Model Number CYF-5

Device Problem Microbial Contamination of Device (2303)

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

Event Date 09/23/2017

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to omsc.Omsc is reviewing the manufacture record of the subject device.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 medical systems corp.(omsc) was informed that as a result of routine microbiological testing by the user facility, the subject device tested positive for baccilus sp.(1cfu/100ml) on (b)(6), tested positive for baccilus sp.And micrococcus(35cfu/100ml) on (b)(6) and tested positive for coagulase negative staphylococci, corynebacterium and ochrobactrum anthropi (42cfu/100ml) on (b)(4).The customer reported that the subject device was reprocessed according to the instruction for use.The subject device had been disinfected 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.Olympus medical systems corp.(omsc) reviewed the manufacturing history of the subject device and confirmed no irregularity.Also, it was confirmed that this device was manufactured on december 9th, 2009.

• Brand Name: FIBERSCOPE "CYF-5", EUROPEAN VERSION
• Manufacturer (Section D): OLYMPUS TOKIO; shinjuku monolith, 2-3-1 nishi-shinjuku, shinjuku-ku; tokio, hamburg 163-0 914; JA 163-0914
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 7032045
• MDR Text Key: 93437133
• Report Number: 8010047-2017-01785
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-5
• Other Device ID Number: 04042761051453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2009
• 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