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 Problems Pneumonia (2011); Vomiting (2144)

Event Date 04/06/2018

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) aam with pmhx htn and etoh abuse.Pt with frequent hospitalizations for asp pneumonia.Peg tube placed changed to gj tube due to frequent aspirations.Was placed at (b)(6) and per wife was vomiting frequently there and sent back for ams/sob determined to be a pneumonia, bal growing klebsiella and serratia treated with cefepime.Was intubated in ed for respiratory distress with decision made in micu to place permanent trach due to frequent aspiration events.Pt was also started on cefepime for possible asp pneumonia.Pt with increased agitation.Pt's agitation markedly decreased following psychiatry service's medication adjustments.Pt's hosp course was otherwise unremarkable, and he was discharged to facility.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: 8151158
• MDR Text Key: 129948183
• Report Number: 8151158
• 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?: Yes
• Date Returned to Manufacturer: 05/04/2018
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 44