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

On may 14, 2018, 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 the staff used a 30cc syringe to aspirate 90cc of fluid into the scope.The user facility utilizes 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.To date, all reprocessing personnel are properly trained and there have been no changes in personnel.On june 8, 2018, the scope was sent to our independent laboratory for microbial testing.The scope tested positive for micrococcus luteus.The scope was then ethylene oxide (eto) sterilized.The.Was returned to olympus for a physical evaluation on june 18, 2018.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.A review of the scope's instrument history shows the scope was purchased on february 17, 2017 with no service records.The scope was repaired and returned to the user facility.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.¿.

Event Description

Patient 2 of 3.On november 2, 2018, the user facility's infection prevention personnel further reported that there were a total of three patient infections and two patient blood samples tested positive for culture that occurred at the user facility following bronchoscopy procedures.This report is in reference to the initial repot submitted on fda mfr# 2951238-2018-00326.The second patient in this report 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.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.It was reported that the physicians are unsure if the scope caused or contributed to the patient infection outbreak.

• 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
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8118314
• MDR Text Key: 129027243
• Report Number: 2951238-2018-00730
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170342110
• UDI-Public: 04953170342110
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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