MAUDE Adverse Event Report: OLYMPUS ENDOBRONCHIAL ULTRASOUND SCOPE; EBUS SCOPE

Model Number BI-UC180F

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Death (1802); Pneumonia (2011); Cancer (3262)

Event Date 11/16/2015

Event Type  Injury  

Event Description

Second medwatch report for same scenario.As part of national outbreaks of cre in endoscopy procedures, our system embarked on a protocol for ercp and eus scopes that included double high level disinfection after each use and weekly environmental cultures.Locally, environmental cultures on the endobronchial ultrasound (ebus) scopes (x2) began 2/25/2016 utilizing the system-wide protocol for the ercp and eus scopes.This was done out of concern from the staff that the ebus scopes presented similar design complexities within the working channel.The protocol includes double high level disinfection after each use and weekly cultures without culture and quarantine unless it is on a known cre patient.Double high level disinfection is done through the medivator automatic endoscopic reprocessor (aer).Scope culturing protocol includes 2 steps; sterile swab dipped in sterile water of the auxiliary port and distal end with tip cut into tryptic soy broth with sterile scissors; sterile brush dipped in sterile water and ran through the working channel then vigorously swished in tryptic vial.Microbiology protocol includes incubation, worked up for turbidity, and then subcultured to blood agar and macconkey agar plates.First weekly culture dated (b)(6) 2016 with no growth.On (b)(6) 2016 culture positive for enterobacter cloacae on brush sample, resulted (b)(6) 2016.Scope recleaned manually and through the aer and retested (b)(6) 2016, resulted as no growth.On (b)(6) 2016 culture positive for enterobacter cloaca on brush, resulted (b)(6) 2016.Scope was pulled out of service and sent to manufacturer for repairs, back in service 04/01/2016.On (b)(6) 2016, culture positive for enterobacter cloacae on brush, resulted (b)(6) 2016.On (b)(6) 2016 culture negative.On (b)(6) 2016, culture negative.On (b)(6) 2016, culture positive for enterobacter cloacae on brush, resulted (b)(6) 2016.Recultured (b)(6) 2016 for insignificant bacteria, no gram negative rods isolated on swab, brush no growth.On (b)(6) 2016, culture positive for enterobacter cloacae on brush, resulted (b)(6) 2016.Scope pulled out of service 05/16/2016.Scope sent to third party vendor 05/24/2016.On 06/03/2016, joint commission investigation and observation of endoscopy cleaning and high level disinfection processes completed, with no deficiencies found.On 06/08/2016, scope back, culture and quarantined.Scope culture positive for enterobacter cloacae on brush and swab samples, resulted (b)(6) 2016.Scope sent to manufacturer 06/10/2016.On 06/10/2016, result of final cultures and date when we were able to link up patients to the specific device.Scope used on 11 patients from (b)(6) 2016.On retrospective review of all enterobacter cloacae respiratory type cultures, two additional cases were found with similar isolates in november of 2015 with concern for cross contamination between the two cases.Case #1 was a patient with a significant pneumonia with cultures positive for enterobacter cloacae who required ebus procedure (b)(6) 2015.Case #2 was a patient who had ebus procedure on (b)(6) 2015 for abnormal chest and workup for cancer and their subcarnial node sample was positive for enterobacter cloacae.Case #2 did not have any post ebus infections and did not require treatment for the positive culture.There are no clinical isolates for genetic testing, however antibiogram patterns are similar.This raised concern for potential cross contamination of case #2's subcarnial node sample.All ebus cases since 11/12/2015 were reviewed for post ebus infections with one case found and reported in a previous report.The patient noted in the previous report had concern for a post procedure pneumonia and died within 10 days of procedure.Also, as noted in relevant tests and other relevant history sections, this patient was also end stage cancer and on hospice, however we are unable to say for sure if the ebus procedure contributed to the patient's death.Ongoing investigation continues with our state epidemiologist.Our second ebus scope continues to test negative.

• Brand Name: ENDOBRONCHIAL ULTRASOUND SCOPE
• Type of Device: EBUS SCOPE
• Manufacturer (Section D): OLYMPUS
• MDR Report Key: 5755839
• MDR Text Key: 48377283
• Report Number: MW5063133
• Device Sequence Number: 1
• Product Code: EOQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/24/2016

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: BI-UC180F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/24/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 60