MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS BRONCHOSCOPE

Model Number 1T180

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Bacterial Infection (1735)

Event Date 04/30/2018

Event Type  malfunction  

Event Description

It was noted c&s obtained during bronchoscope procedure of ten pts were all growing pseudomonas aeruginosa, serratia marcescens.This was traced back to index pt with these organisms as well as chryseobacterium indologenes in sputum.Three pts culture included chryseobacterium indologenes, three grew enterobacter, and one strep pneumoniae.Further investigation revealed the same bronchoscope was used on all of the aforementioned pts.Culture of this scope revealed 2+ serratia marcescens, 2+ chryseobacterium indologenes, 2+ enterobacter cloacae, and 2+ pseudomonas aeruginosus.It was identified that this same bronchoscope had a loose cap on biopsy port.This area was cultured revealing 2+ growth of serratia marcescens, 2+ growth of chryseobacterium indologenes, 2+ growth of enterobacter cloacae, and 2+ growth of pseudomonas aeruginosus.Some pts were treated by providers based on c&s results.Based on what is known, no pt developed an infection related to this issue.All scopes were disinfected using medivator plus.No issues were identified related to high level disinfection.

• Brand Name: BRONCHOSCOPE
• Type of Device: BRONCHOSCOPE
• Manufacturer (Section D): OLYMPUS CORPORATION OF THE AMERICAS
• MDR Report Key: 7784255
• MDR Text Key: 117297673
• Report Number: MW5079139
• Device Sequence Number: 0
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1T180
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2018
• 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