EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-01-18 for EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F manufactured by Olympus Medical Systems Corp..

Event Text Entries

[133700718] The scope was returned to olympus (b)(4) and will be shipped to the national customer service center in san (b)(6). The scope is currently pending evaluation. Olympus will continue to investigate this complaint to obtain more detailed information regarding the reported complaint. If additional information becomes available, this report will be updated and supplemented accordingly.
Patient Sequence No: 1, Text Type: N, H10


[133700719] Olympus was informed that two patients developed infections after undergoing diagnostic endobronchial ultrasound bronchoscopy (ebus) procedures in (b)(6) 2018. Of that, one patient (patient2) reportedly expired. The user facility? S ambulatory care manager reported that the patient? S death is under investigation and that cross contamination has not been ruled out as a possible contributing factor. Additionally, the user facility reported that a non-olympus automated endoscopic resprocessor steris 1 is utilized to high level disinfect the subject scope. This is 2 of 2 report.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2951238-2019-00379
MDR Report Key8262979
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-01-18
Date of Report2019-04-24
Date Mfgr Received2019-03-27
Date Added to Maude2019-01-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. CONNIE TUBERA
Manufacturer Street2400 RINGWOOD AVENUE
Manufacturer CitySAN JOSE CA 95131
Manufacturer CountryUS
Manufacturer Postal95131
Manufacturer Phone4089355124
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE
Generic NameULTRASONIC BRONCHOFIBERVIDEOSCOPE
Product CodePSV
Date Received2019-01-18
Returned To Mfg2018-11-22
Model NumberBF-UC180F
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerOLYMPUS MEDICAL SYSTEMS CORP.
Manufacturer Address2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-01-18

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