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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS BRONCHOSCOPE

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OLYMPUS CORPORATION OF THE AMERICAS BRONCHOSCOPE Back to Search Results
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.

 
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Brand NameBRONCHOSCOPE
Type of DeviceBRONCHOSCOPE
Manufacturer (Section D)
OLYMPUS CORPORATION OF THE AMERICAS
MDR Report Key7784255
MDR Text Key117297673
Report NumberMW5079139
Device Sequence Number0
Product Code EOQ
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
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
Date FDA Received08/14/2018
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1T180
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/14/2018 Patient Sequence Number: 1
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