MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERAII BRONCHOVIDEOSCOPE

Model Number BF-1T180

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to olympus for evaluation.The user facility and olympus is arranging a date to visit the site to observe an unidentified organization gather cultures from the bronchoscope as part of their investigation of the reported events.In addition, an olympus endoscopy support specialist (ess) visited the user facility on october 19, 2016 to assess their reprocessing practices and provided reprocessing training.The ess found the following reprocessing deviations: the user facility was not suctioning the scope after manual brushing.Instead, the user facility was using a non olympus endoscope flushing aid (scope buddy manufactured by (b)(4)) to flush the channels of the scope.The cause of the reported positive culture could not be determined but improper maintenance of the device cannot be ruled out as a contributory factor.Chapter 3 of the reprocessing instruction manual states, ¿turn the suction pump on.When using the biopsy valve (md-495), attach the biopsy valve¿s cap.Immerse the distal end of the insertion section in detergent solution.Depress the suction valve and aspirate detergent solution into the instrument channel for 30 seconds.¿.

Event Description

Olympus was informed that 13 patients tested positive for pseudomonas aeruginosa.Approx 2 out of the 13 patients were identified as having comorbidity medical conditions and have since expired.The dates of the two deaths are unknown.It was also reported that medical intervention was provided to the patients; however, no details were provided.In addition, the bronchovideoscope tested positive for pseudomonas aeruginosa after reprocessing.There was biomatter found underneath the o-ring of the scope.The scope was removed from service on september 16, 2016.This is 3 of 13 reports.

Manufacturer Narrative

The user facility further reported on (b)(6) 2017 that they have no plans in returning the scope to olympus for evaluation.In addition, the user facility reported that the frequency of use for the scope is approximately 10 times a month from (b)(6) through mid (b)(6) 2016.It was also reported that a non olympus accessory (covidien (b)(4)) was attached to the biopsy port.A non olympus medivator dsd automated endoscope reprocessor (aer) machine alongside medivator scope buddy connector is used to reprocess the scope.The scope is hung in a ventilated cabinet to dry.It was also reported that the (b)(4) patients that tested positive for pseudomonas aeruginosa underwent bronchoscopy procedures in (b)(6) and (b)(6) of 2016.The date that the infections were confirmed was on (b)(6) 2016.In addition, the original equipment manufacturer (oem) performed a reproduction test on a bf-1t180 scope with a similar non olympus medtronic edge adapter borrowed from the user facility.It was found that the instrument channel port of the bf-1t180 scope did not come loose.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information received from the olympus medical systems corporation (omsc).Omsc conducted a root cause analysis of this report and other similar complaints related to loose biopsy ports.The root cause analysis included utilizing an olympus adaptor and non-olympus adaptors (covidien and medivator) in an attempt to identify the possible causes or contributory factors that could lead to ¿loose biopsy port¿ on bronchoscopes.Based on omsc¿s analysis it was determined that the biopsy port (k-port) will not become loose during normal use.Omsc found that using a covidien adaptor possibly leads to greater torque forces than the current manufacturing specification for the biopsy port, resulting in loosening of the biopsy port.Olympus does not support or recommend the use of a non-olympus biopsy port adaptor.The instructions for use (ifu) instruct the user to inspect the endoscope prior to use, and inspect the control section and the endoscope connector for excessive scratching, deformation, loose parts, or other irregularities.In the event that such irregularities are observed, the ifu instruct user to stop use of the device and contact olympus.The ifu provides list of compatible endotherapy and accessories to be used with the bronchoscope.The ifu states that using an incompatible accessories or equipment can result to patient or operator injury and/or equipment damage.In an effort to prevent biopsy port looseness, omsc plans on creating an even more robust tightening force specification for the biopsy port to be resistant to abnormally high applied forces.The change in specification affects ¿respiratory endoscopes.¿.

Manufacturer Narrative

Olympus received a legal document on december 27, 2017 alleging that after the patient had undergone a bronchoscopy procedure on (b)(6) 2016, the presence of pseudomonas bacteria was found, leading to the development of pseudomonas pneumonia, for which the patient received treatment.On (b)(6) 2016 the patient underwent a second chest ct scan which revealed lung abnormalities.As a result, the patient was readmitted to undergo a second bronchoscopy procedure on (b)(6) 2016, with the same bronchoscope used in the first bronchoscopy procedure.The results of the second bronchoscopy procedure again showed the presence of pseudomonas bacteria.The patient was treated with iv antibiotics via picc line and inhaled antibiotics.The inhaled antibiotic treatment resulted in severe irritation and ulcers to the patient¿s vocal chords, requiring ent treatments and speech therapy.On (b)(6) 2016, the patient was notified by the user facility that the bronchoscope used during the patient¿s previous procedures may have presented a risk for infection.The user facility also informed the patient that twelve (12) other patients had been infected.Due to the pseudomonas infection on (b)(6) 2016, the patient had to undergo an open lung biopsy; which revealed lung scarring.The patient is now in need of a lung transplant and is on a supplemental oxygen support.

• Brand Name: EVIS EXERAII BRONCHOVIDEOSCOPE
• Type of Device: BRONCHOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6077932
• MDR Text Key: 59116850
• Report Number: 2951238-2016-00826
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK061313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-1T180
• Device Catalogue Number: BF-1T180
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/11/2016
• Initial Date FDA Received: 11/03/2016
• Supplement Dates Manufacturer Received: Not provided; 09/08/2017; 12/27/2017
• Supplement Dates FDA Received: 03/14/2017; 09/29/2017; 01/19/2018
• 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; Required Intervention