MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA BRONCHOVIDEOSCOPE

Model Number	BF-1T160
Medical Device Problem Codes	Detachment Of Device Component (1104); Microbial Contamination of Device (2303)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	12/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As part of our investigation, olympus made multiple follow ups with the user facility by telephone and in writing in an attempt to gather additional information on the reported event; however, no additional information was obtained.The scope was not returned to olympus for evaluation.Olympus performed an instrument service history review on the reported scope and found no service history information.In addition, an olympus endoscopy support specialist (ess) visited the user facility on (b)(6) 2017 to observe the facility¿s reprocessing practice and to provide a reprocessing training.The ess found no reprocessing deviations.The cause of the reported event could not be conclusively determined; however, improper maintenance could not be ruled out as a contributing factor to the reported event.The instruction manual for use states, ¿this instrument does not contain any user-serviceable parts.Do not disassemble, modify, or attempt to repair it; patient or operator injury and/or equipment damage may result.Equipment that has been disassembled, repaired, altered, changed, or modified by persons other than olympus¿ own authorized service personnel is excluded from olympus¿ limited warranty and is not warranted by olympus in any manner.¿ if additional information is received at a later time or if the device becomes available, this report will be supplemented.
Event or Problem Description
Olympus was informed that during an unspecified procedure, a patient may have been infected with an unknown bacterium using an olympus bronchoscope.It was also reported that during reprocessing, the bronchoscope was found with debris under the biopsy port and the biopsy port was found loose.The user facility reported that the olympus bronchoscope was purchased from a non-olympus third party entity and that the scope is also serviced at a non-olympus third party entity.The patient¿s outcome is unknown.

• Brand Name: EVIS EXERA BRONCHOVIDEOSCOPE
• Common Device Name: BRONCHOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 7149493
• Report Number: 2951238-2017-00789
• Device Sequence Number: 10493508
• Product Code: EOQ
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: PK963033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/27/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: BF-1T160
• Device Catalogue Number: BF-1T160
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 12/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1