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

Model Number BF-P190

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

As part of our investigation, olympus made multiple follow ups with the user facility by telephone and in writing in an attempt to gather additional information on the reported event; however, no additional information was obtained.The scope was returned to olympus for evaluation; however, the device evaluation is still pending completion.The scope will be sent to our independent laboratory for microbial testing and ethylene oxide (eto) sterilization.In addition, an olympus endosocpy support specialist (ess) visited the user facility to observe the facility¿s reprocessing practice and to provide a reprocessing training.The ess observed only one minor reprocessing deviation.The staff used a 30cc syringe to aspirate 90cc of fluid into the scope.The scope is reprocessed in a non-olympus automated endoscope reprocessor (aer) and stored in a scope cabinet.The ess provided the user facility staff a reprocessing wall chart and a dvd step by step video on how to reprocess a bronchoscope.This report will be supplemented when the device evaluation has been completed and if additional information becomes available at a later time.

Event Description

Olympus was informed that an unspecified carbapenem-resistant enterobacteriaceae (cre) outbreak occurred at the user facility with multiple patients.The physicians are unsure if the scope caused or contributed to the patient infection outbreak.

Manufacturer Narrative

The scope was sent to an independent laboratory for microbial testing.The scope tested positive for micrococcus luteus.The scope was then ethylene oxide (eto) sterilized and returned to olympus for a device evaluation.A visual inspection on the received condition of the scope and was unable to find any signs of foreign material/substance/stain inside the biopsy channel, biopsy port and channel opening when inspected with an olympus boroscope and telescope test equipment.In addition, there were no signs of foreign substance/materials found with the insertion tube, bending section cover, bending section cover glue, distal end cover, light guide lens/glue, and objective lens/glue.There were also no sign of missing parts with the scope.The scope passed the leak test.The cause of the reported event could not be confirmed.However, improper maintenance could not be ruled out as a contributing factor to the reported positive culture.The instruction manual provides warning which states, ¿all channels of the endoscope and all accessories used with the endoscope during the patient procedure must be reprocessed after each patient procedure, even if the channels or accessories were not used during the patient procedure.Insufficient reprocessing of these components may pose an infection control risk to patients and/or operators.¿.

Manufacturer Narrative

This supplemental report is being submitted to provide a correction to the initial report based on additional information from the user facility.The infection prevention personnel further reported that following bronchoscopy procedures, three patient infections were reported and two patient samples tested positive for culture.Patient(b)(6) became infected with cre, type erta resistant entrobacter cloacae.The user facility was unable to obtain patient¿s secondary condition due to patient¿s condition.The patient¿s blood sample was obtained and was positive for enterobacter cloacae (not resistant).The patient has been treated with cefepime.Patient#1 became infected with cre, type imi/mero pseudomonas aeruginosa.The patient¿s pre-existing condition was iii pneumonia.The patient¿s blood culture was obtained and the results were negative.The patient has been treated with cefepime.Patient#2 became infected with cre, type mero resistant acinetobacter.The patient¿s pre-existing condition was shortness of breath with hypoxia.The patient¿s blood culture was obtained and positive for staphylococcus capitis.The patient has been treated with linezolid.The reprocessing cleaning and disinfectant solutions were revital ox and valsure, resert and the minimum effective concentration was checked prior to each use; the user facility utilized the steris 1e, automated endoscope reprocessing machine (aer) and there are no reported issues with the steris 1e.The last preventative maintenance of the steris 1e is unknown.During manual cleaning, a single use hallmark brush (model unknown) is used.Pre-cleaning is performed immediately after use, the scope is cleaned with an impregnated enzymatic sponge with excess fluid suctioned through the biopsy port.The olympus endoscopy support specialist performed the last in-service on may 15, 2018.All reprocessing personnel are properly trained and there were no changes in personnel.The scope¿s instrument history was reviewed which showed the scope was purchased on february 17, 2017, with no previous repair records.The scope was repaired and returned to the user facility.

Manufacturer Narrative

B1 updated to indicate adverse event.

• Brand Name: EVIS EXERA III BRONCHOVIDEOSCOPE
• Type of Device: BRONCHOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 7559224
• MDR Text Key: 109739163
• Report Number: 2951238-2018-00326
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170342110
• UDI-Public: 04953170342110
• Combination Product (y/n): N
• PMA/PMN Number: K121959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/13/2019

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-P190
• Device Catalogue Number: BF-P190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/04/2018
• Initial Date FDA Received: 05/31/2018
• Supplement Dates Manufacturer Received: 06/15/2018; 11/02/2018; 10/29/2019
• Supplement Dates FDA Received: 07/03/2018; 11/20/2018; 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other