MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION OLYMPUS; FLEXIBLE BRONCHOSCOPE

Model Number BF-P190

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

Patient Problems Bacterial Infection (1735); Death (1802); Hypoxia (1918); Paralysis (1997); Respiratory Distress (2045); Seizures (2063)

Event Date 04/13/2018

Event Type  Death  

Event Description

Pt involved in a multi-drug resistant cluster in which a bronchoscope was identified as a commonality.A (b)(6) male from (b)(6) health (since 2007) for tbi, cva with right sided hemiplegia, seizure d/o, mdd / psychosis (nurse at (b)(6) health reported schizophrenia), strabismus, dysphagia, and recurrent aspiration pna who presented with acute hypoxic respiratory failure on (b)(6) 2018.Presented on 100% nrb due to sob and hypoxia with decreased mentation.He was only responding to painful stimuli.He was intubated for airway protection and started on zosyn and vancomycin.Had mini bal which grew (b)(6) and some yeast so fluconazole was added.Extubated (b)(6) and intubated (b)(6).Abx changed from zosyn / vanc / fluconazole to zosyn / linezolid / fluconazole and he clinically started to improve.Had bronch (b)(6) which grew resistant strains of acinetobacter.Given he had clinically improved on previous abx, no changes were made.Pt expired on (b)(6) 2018 due to cardiac arrest.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 CORPORATION; southborough MA
• MDR Report Key: 8151174
• MDR Text Key: 129946840
• Report Number: 8151174
• 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
• 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): Death
• Patient Age: 48 YR
• Patient Weight: 76