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

Model Number	BF-Q180
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As part of our investigation, the service center followed up with the user facility regarding the reported event and was informed that the scope was not eto sterilized.The cleaning and disinfectant solutions used with the endoscope are ecolab optipro multi-enzymatic and hld with medivators rapicide pa( part a and b).The type of aer being used to reprocess the endoscope is a medivator dsd edge serial number (b)(4).There have not been any issues noted with the aer.The last pm for the aer was (b)(6) 2020.It is unknown when the last reprocessing in-service was conducted by an olympus endoscopy support specialist.All reprocessing personnel are trained on how to properly reprocess an endoscope.The endoscope is being stored in a medivator esc drying cabinet.An olympus endoscopy support specialist (ess) was dispatched to the user facility to assess their reprocessing practices and to provide reprocessing training if necessary.To date, the ess visit has not been finalized.In addition, the device was returned to the service center for evaluation.A visual inspection on the device found the bending section rubber stretched/removed/dry.An issue was noted with the continuity of the bending section.The image was checked and found a minor orange saturation.Light scratches were observed on the control body and scope connector of the scope.The cause of the reported event was determined.The legal manufacturer will review the content of this complaint for further evaluation.
Event or Problem Description
The service center was informed that the scope cultured positive multiple times after reprocessing.The user facility reported that the suction, biopsy port and tip were sampled using a swab and cultured.The microorganisms were detected from the suction port.The microorganism detected was staph.Bacillus and yeast.On (b)(6) 2019 there was bacillus species growing on the suction.This scope had not been used since (b)(6) 2019 when it was cultured.Staph.Aureus was present on the scope on (b)(6) 2020.There was no growth within five days after the scope was re-cultured on (b)(6) 2020.The scope was reprocessed on (b)(6) 2020 and the suction connector tested positive for yeast on (b)(6) 2020.The scope was disinfected again (hld) and re-cultured with no growth on (b)(6) 2020.The device sampling and culturing were performed as a random monthly testing.The device was not used on a patient with a known infection of the same microorganism.No patients were cultured and there were no patient infections reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and the in-service provided to the user facility staff.An olympus endoscopy support specialist (ess) has since provided an in-service for the user facility staff.The in-service included all pre-cleaning and manual cleaning information contained in the olympus manual.Upon completion of the in-service, the staff stated they understood all instructions that were provided.Based on the legal manufacturer's investigation, the device history record was reviewed and no issues were identified that could have caused or contributed to the reported issue.Although the legal manufacturer cannot conclusively determine the cause of the reported issue, the legal manufacturer suspects the issue may have occurred due to insufficient reprocessing or contamination possibly occurred during microbiological testing.We could not confirm any factor from the design nor structure of the device that would cause the reported event.The device¿s instructions for use provides the following warning: after using this instrument, reprocess and store it according to the instructions given in the endoscope¿s companion ¿reprocessing manual¿ with your endoscope model listed on the cover.Using improperly or incompletely reprocessed or stored instruments may cause patient cross-contamination and/or infection.

• Brand Name: EVIS EXERA II BRONCHOVIDEOSCOPE
• Common Device Name: BRONCHOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10801342
• Report Number: 8010047-2020-08646
• Device Sequence Number: 14345036
• Product Code: EOQ
• UDI-Device Identifier: 04953170339301
• UDI-Public: 04953170339301
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K061313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BF-Q180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 12/13/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 01/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1