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

Model Number CYF-5

Device Problem Microbial Contamination of Device (2303)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to omsc.The exact cause could not be determined at present.If significant additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that during routine surveillance culturing test by the facility, the biopsy channel of the subject device repeatedly tested positive for unspecified bacteria.The numbers of bacteria were as follows; (b)(6).The subject device had been manually reprocessed with peracetic acid.There was no report of patient infection associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to additional information.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 testing.In the additional test, the testing indicated no microbial growth for the subject device.Omsc reviewed the manufacture history of the subject device and confirmed no irregularity the exact cause could not be determined at present.If significant additional information is received, this report will be supplemented.

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Type of Device: CYSTONEPHROFIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7326401
• MDR Text Key: 102348073
• Report Number: 8010047-2018-00407
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• PMA/PMN Number: PK032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• 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: 04953170339417
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1