EVIS EXERAII BRONCHOVIDEOSCOPE UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-02-12 for EVIS EXERAII BRONCHOVIDEOSCOPE UNKNOWN manufactured by Olympus Medical Systems Corp..

Event Text Entries

[188989650] The subject device has not been returned to omsc but was returned to olympus europa (b)(4). (oekg). Oekg sent the device to a third party laboratory for microbiological testing. As a result of the testing, no microbe was detected from the sample collected from the distal end and instrument channel of the subject device. The exact cause of the reported event could not be conclusively determined at this time. If additional information becomes available, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10


[188989651] Olympus medical systems corp. (omsc) was informed that 36 patients were infected with mycobacterium lentiflavum. The facility owns olympus bronchovideoscope model bf-q180 (serial number: (b)(4), bf-uc180f (serial number: (b)(4), bf-1th190 (serial number: (b)(4) and bf-1t60 (serial number: (b)(4), and may have been used for these patients, but it is unknown which scope was used for which patient. The devices had been reprocessed with an olympus automated endoscope reprocessor model minietd2 (not available in the usa). Other detailed information such as the outcome of patients was not provided. Omsc is submitting 36 medical device reports according to the number of the infected patients. This is 33 of the 36 reports.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8010047-2020-01263
MDR Report Key9698492
Report SourceFOREIGN,USER FACILITY
Date Received2020-02-12
Date of Report2020-03-06
Date Mfgr Received2020-02-11
Date Added to Maude2020-02-12
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 ContactMR KAZUTAKA MATSUMOTO
Manufacturer Street2951 ISHIKAWA-CHO
Manufacturer CityHACHIOJI-SHI, TOKYO-TO 192-8507
Manufacturer CountryJA
Manufacturer Postal192-8507
Manufacturer Phone426425177
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEVIS EXERAII BRONCHOVIDEOSCOPE
Generic NameBRONCHOVIDEOSCOPE
Product CodeEOQ
Date Received2020-02-12
Model NumberUNKNOWN
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
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 2020-02-12

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