EVIS EXERA II BRONCHOVIDEOSCOPE BF-Q180

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-10 for EVIS EXERA II BRONCHOVIDEOSCOPE BF-Q180 manufactured by Olympus Medical Systems Corp..

Event Text Entries

[183139565] The service center was informed that four patients contracted a cytomegalovirus infection after undergoing a procedure with the facility? S bronchoscopes. The user facility reported that these were inpatients in the facility? S burn or respiratory care unit. The patient samples were sent an independent laboratory and cultured positive. As a result, the user facility acquired a sample of the disinfectant flushed from the scope; however, the culture results are unknown at this. The samples from the scopes are being retained at the facility and refrigerated. The scopes were taken out service at that time; however may have been put back into service due to limited inventory. The patient? S course of treatment is unknown. This is 2 of 8 reports. As part of our investigation of this report, 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. The scope is being retained at the user facility at this time. An investigation is ongoing to obtain additional information regarding the reported event. This report is to account for patient 1.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2951238-2020-00364
MDR Report Key9813050
Date Received2020-03-10
Date of Report2020-03-10
Date of Event2020-02-21
Date Facility Aware2020-02-24
Report Date2020-02-24
Date Reported to Mfgr2020-02-24
Date Added to Maude2020-03-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEVIS EXERA II BRONCHOVIDEOSCOPE
Generic NameBRONCHOVIDEOSCOPE
Product CodeEOQ
Date Received2020-03-10
Model NumberBF-Q180
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerOLYMPUS MEDICAL SYSTEMS CORP.
Manufacturer Address2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO 192-8507 JA 192-8507


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-10

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