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

Model Number BF-1T160

Device Problems Detachment Of Device Component (1104); Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 12/07/2017

Event Type  Injury  

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 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
• Type of Device: BRONCHOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 7149493
• MDR Text Key: 95903006
• Report Number: 2951238-2017-00789
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK963033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-1T160
• Device Catalogue Number: BF-1T160
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1