MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. FIBERSCOPE "URF-P5", SET E

Model Number WA26730A

Device Problem Microbial Contamination of Device (2303)

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

Event Date 02/15/2018

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to omsc but was returned to olympus (b)(4).(b)(4) sent this device to a third party laboratory for additional microbiological testing.The additional microbiological testing indicated no microbial growth for the instrument channel of this device.Therefore, it cleared the (b)(4) guideline.Also, olympus reviewed the manufacturing history of this 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 medical systems corp.(omsc) was informed that as a result of routine microbiological testing by the user facility, the instrument channel of the subject device tested positive for microbes as follows.The user facility reported that this device was reprocessed manually with peracetic acid.There was no report of patient infection associated with this report.First time, 2 cfu/100 ml (unspecified microbe).Second time, 1 cfu/100 ml (unspecified microbe).Third time, 2 cfu/100 ml (unspecified microbe).

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 the device was manufactured on november 1st, 2010.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.

Manufacturer Narrative

This supplemental report is submitting to correct "device product code".

• Brand Name: FIBERSCOPE "URF-P5", SET E
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7360841
• MDR Text Key: 103557460
• Report Number: 8010047-2018-00490
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: PK912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA26730A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/26/2018
• Initial Date FDA Received: 03/22/2018
• Supplement Dates Manufacturer Received: 05/03/2018; 02/13/2019
• Supplement Dates FDA Received: 05/31/2018; 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1