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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II DUODENOVIDEOSCOPE Back to Search Results
Model Number TJF-Q180V
Device Problem Microbial Contamination of Device (2303)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
The forceps elevator was replaced according to an olympus field corrective action on july 22, 2016.The subject device has not been returned to olympus medical systems corp.But was returned to olympus (b)(4).Following additional high level disinfection at (b)(4), the subject device was sent to a third party laboratory for additional microbiological testing.In the test, the test result indicated no microbial growth for the subject device.After the additional microbiological testing, (b)(4) continued with the incoming inspection in the repair center.During incoming inspection the endoscope passed the leakage test successfully and olympus performed a technical evaluation.Olympus found signs of wear and tear at the distal end of the subject device as there were slight bending section damages and cementing deterioration that were classified as "minor" repairs.The exact cause could not be determined at present.Olympus is planning to follow up with the facility to obtain additional information.If significant additional information is received, this report will be supplemented.
 
Event Description
Olympus (b)(4) was informed that two patients tested positive for oxa48 producing klebsiella pneumonia on (b)(6) 2017 after having undergone endoscopic retrograde cholangiography (ercp) using the subject device.One of the two patients reportedly had fever after the ercp.It was reported that the test result of the microbiological testing for the subject device at the facility did not reveal the bacteria.On (b)(6) 2017, (b)(4) received an incident report from (b)(6) and was informed about additional 2 cases of infection (total 4 cases of patient ¿ infections and/or colonization of high resistant bacteria¿ ) at the facility.The incident report also reported that the subject device was returned from repair on (b)(6) 2017.The subject device had been reprocessed using non-olympus automated endoscope preprocessor (soluscope 4) with peracetic acid.This is four of four reports.Please cross reference the following mfr.Report numbers: 8010047-2017-01562, 8010047-2017 -01564.
 
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Brand Name
EVIS EXERA II DUODENOVIDEOSCOPE
Type of Device
DUODENOVIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
Manufacturer Contact
katsuaki morita
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key7027139
MDR Text Key92211620
Report Number8010047-2017-01767
Device Sequence Number1
Product Code FDT
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
PK143153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 11/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberTJF-Q180V
Other Device ID Number04953170339967
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/19/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/23/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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