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

Model Number URF-P5

Device Problem Microbial Contamination of Device (2303)

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

Event Date 11/26/2018

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, 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 sample collected from all channels of the subject device tested positive for stenotrophomonas maltophilia (29cfu/100ml).The device had been reprocessed with a non-olympus automated endoscope reprocessor, soluscope series 4, 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.The user facility did not reprocessed the device with a non-olympus automated endoscope reprocessor, soluscope, using peracetic acid, and had been manually reprocessed the device using peracetic acid.The subject device has not been returned to olympus medical systems corp.(omsc) but was returned to olympus (b)(4).(b)(4) sent the device to a third party laboratory for microbiological testing.As a result of the testing, no microbe was detected from the sample collected from all channels of the subject device.The testing result was target level in the (b)(6) guideline.Omsc reviewed the manufacture history of the device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Manufacturer Narrative

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

• Brand Name: FIBERSCOPE "URF-P5", SET E
• Type of Device: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 8195241
• MDR Text Key: 132435433
• Report Number: 8010047-2018-02554
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: K912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• 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: URF-P5
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 12/26/2018
• Supplement Dates Manufacturer Received: 12/28/2018; 02/13/2019
• Supplement Dates FDA Received: 01/24/2019; 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1