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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERAII BRONCHOVIDEOSCOPE Back to Search Results
Model Number BF-1T180
Device Problems Biofilm coating in Device (1062); Loose or Intermittent Connection (1371)
Patient Problems Bacterial Infection (1735); No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative

The scope was returned to the service center however the investigation is ongoing. A review of the service history of the scope indicates the scope was purchased on (b)(6) 2009 and there are four repairs in the past three years. The last repair involved a loose biopsy port. In addition, an endoscopy support specialist (ess) was requested to be dispatched to the user facility to observe the facility¿s reprocessing practice and to provide a reprocessing training. To date, the ess visit has not been finalized. If additional information becomes available, this report will be supplemented accordingly.

 
Event Description

The service center was informed that the scope's biopsy port was noted to be loose. The biopsy port was reportedly taken apart and foreign residue was present. There was no patient injury reported, however, the user facility reported the scope was linked to two cases of possible contamination. This is for 2 of 2 reports.

 
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Brand NameEVIS EXERAII BRONCHOVIDEOSCOPE
Type of DeviceBRONCHOVIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA 192-8507
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key9238618
MDR Text Key202877884
Report Number8010047-2019-03711
Device Sequence Number1
Product Code EOQ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK061313
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/29/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/25/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberBF-1T180
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/02/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/02/2020
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

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