MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OLYMPUS; FLEXIBLE BRONCHOSCOPE

Model Number BF-P190

Device Problems Component Incompatible (1108); Failure to Sense (1559); Device Operates Differently Than Expected (2913)

Patient Problem Pneumonia (2011)

Event Date 03/31/2018

Event Type  Injury  

Event Description

Pt involved in a multi-drug resistant cluster in which a bronchoscope was identified as a commonality.A (b)(6) male with h/o alcohol abuse and alcohol withdrawal seizures who presents after having two witnessed seizure-like episodes.Was unable to protect airway and aspirated tube feeds - developed enterobacter pneumonia for which he completed treatment.Pt likely developed wernicke / korsakoff throughout his hosp course.Remained stable, he is awake but not fully oriented, he is able to cooperate and answers basic questions.He completed antibiotic course.During the review of the organisms, it was noted that the pt had received a bronchoscopy involving the same scope.While the organisms are not considered to be related, out of an abundance of caution, we requested that the scope be removed from service and sent to mfr for inspection to ensure integrity as we continued our focus on hand hygiene, environmental cleaning, and adherence to the appropriate transmission based precaution.

• Brand Name: OLYMPUS
• Type of Device: FLEXIBLE BRONCHOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP. ; southborough MA
• MDR Report Key: 8151163
• MDR Text Key: 129947543
• Report Number: 8151163
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BF-P190
• Device Catalogue Number: BF-P190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/29/2018
• Distributor Facility Aware Date: 04/24/2018
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/04/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 75