MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. BRONCHOFIBERSCOPE

Model Number	BF-TE2
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to omsc for evaluation.Omsc reviewed the manufacturing 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 is received, this report will be supplemented.
Event or Problem Description
Olympus medical systems corp.(omsc) was informed that three patients infected with pseudomonas aeruginosa after an unspecified procedure using the subject device.One of three patients reportedly died.Olympus contacted the user facility to obtain further information, such as the outcomes of the patients, the date of the procedures, the date of determination of the infections and the date of the death, but they did not provide any information.As result of microbiological tests by the user facility, following microbes were detected from the sample collected from the device.However, the tests result cleared the french guideline.[first time; (b)(6) 2018].No microbe detected.[second time; (b)(6) 2018].Bacillus gram positive non spore forming bacteria (2cfu / 100ml).The device had been reprocessed manually by the user facility.Olympus is submitting mdr according to the number of the patients who were infected potentially associated with the endoscope.This is 3rd of 3 reports.(it is a report of the patient who infected but not died).

• Brand Name: BRONCHOFIBERSCOPE
• Common Device Name: BRONCHOFIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 8415164
• Report Number: 8010047-2019-01255
• Device Sequence Number: 1955053
• Product Code: EOQ
• UDI-Device Identifier: 04953170063008
• UDI-Public: 04953170063008
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K023984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: BF-TE2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 03/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other