MAUDE Adverse Event Report: OLYMPUS OF AMERICA OLYMPUS; BRONCHOSCOPE

Model Number	BF1T180
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Bacterial Infection (1735); Pseudoaneurysm (2605)
Date of Event	09/09/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Pt was seen by pulmonologist and has history of mycobacterium.Had a bronchoscopy on (b)(6) 2016 with bronchial washing and biopsy obtained for cultures x2.Cultures indicate sensitive to gentamycin.Results returned positive for pseudomonas aeruginosa.Review of facility data reflects a recent trend of increased diagnosis of pseudomonas aeruginosa in pts with bronchoscopy.This device is an olympus bronchoscope that is used on a pt, then cleaned and processed according to the mfr's guidelines.The device is intended for reuse following proper cleaning techniques.Upon review, this device was found to have a defective port that was moving (is supposed to be stationary) and the o-ring was displaced allowing bio-matter to accumulate.Dates of use: (b)(6) 2016.

• Brand Name: OLYMPUS
• Common Device Name: BRONCHOSCOPE
• Manufacturer (Section D): OLYMPUS OF AMERICA
• MDR Report Key: 6021641
• Report Number: MW5065337
• Device Sequence Number: 1037406
• Product Code: EOQ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BF1T180
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 24 YR
• Patient Weight: 72