MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. UNKNOWN

Model Number UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

To the best of our knowledge, the subject devices were not returned to olympus medical systems corp.And the serial numbers of the subject devices were not reported to omsc.

Event Description

Olympus medical systems corp (omsc)conducted a retrospective review on clinical publication and noticed on june 28, 2017 that a medical article published in 2016, ¿a pseudo-outbreak of pseudomonas putida and stenotrophomonas maltophilia in a bronchoscopy unit¿, journal of respiration: 274-278 (2016).This article reported an investigation of outbreaks of pseudomonas putida and stenotrophomonas maltophilia contamination in a hospital in spain between february 7 and march 4, 2013.The article reports that models of olympus bronchoscope used in the facility were associated with contamination found in bronchial washing (bw) specimens.The article reports that of 39 cases with positive bw specimens, 28 cases were positive for pseudomonas putida and stenotrophomonas maltophilia, 9 only for pseudomonas putida and 2 only for stenotrophomonas maltophilia.Fifteen patients had mixed cultures for other microorganisms.The patient¿s median age was 63 years (range 51-75), and 28 were male.There were no serious clinical complications in this complaint.The patients developed neither clinical signs or symptoms of infection nor radiological alterations, but 21 patients were treated with antibiotics (pseudomonas putida and stenotrophomonas maltophilia) and 13 were receiving antibiotic treatment before bronchoscopy.This study involved a total of 8 different models of a bronchoscope.These devices had been reprocessed according to the manufactures specifications and national guideline using an olympus automated endoscope reprocessor model etd-3 (not available in the usa).The article reported that the author described a pseudo-outbreak related to only two models of bronchoscopes, bf-1t160 and bf-160.Only one procedure was associated with the olympus bronchoscopy model bf-1t180.As part of this investigation, scopes and environmental cultures were taken.And the study reported that two models of olympus bronchoscope, which are the bf-1t160 in 12 and bf-160 in 18, tested positive for pseudomonas putida or stenotrophomonas maltophilia.It was not reported that bf-1t180 tested positive.No serial numbers of these olympus bronchoscopes were provided.Other samples taken from cleaning brushes, diluted cleaning solutions and sink also tested positive for same microorganisms.In a subsequent survey, the etd-3 was examined.The sample from the aer was negative, but the filter on the water lines was tested positive for pseudomonas putida or stenotrophomonas maltophilia.Omsc reviewed its mdr files related to above olympus bronchoscopes and could not confirm the incident reports in the files.Based on the information from the article, olympus is submitting 39 initial mdrs to account for the 39 contamination of the bw specimens.This is 35 of 39 reports.

• Brand Name: UNKNOWN
• Type of Device: UNKNOWN
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 6746279
• MDR Text Key: 81117326
• Report Number: 8010047-2017-01099
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other