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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III DUODENOVIDEOSCOPE

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AIZU OLYMPUS CO., LTD. EVIS EXERA III DUODENOVIDEOSCOPE Back to Search Results
Model Number TJF-Q190V
Device Problem Microbial Contamination of Device (2303)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Event Description
The customer reported to olympus that during routine microbiological testing, the evis exera iii duodenovideoscope tested positive for an unexpected contamination.The testing was performed after a therapeutic endoscopic retrograde cholangiopancreatography procedure.The user did not report any contamination or any other serious deterioration in state of health of any person, to which the scope could have been a contributory cause.Additional information from the olympus employee reported that upon follow-up at the site and discussing the positive culture report with the customer, it was discovered the facility had two potential patients post procedure infections.Both instances the patient had an ercp- endoscopic retrograde cholangiopancreatography procedure before the infection and a culture positive scope was used in the procedure.The customer has not disclosed the date the scopes were cultured, and the type/growth of microbiological organism tested.The facility is reported to be inquiring further details from the infection prevention control.2 similar occurrrences have been reported by the customer for patients having post-procedure infections at their facility with the patient identifiers: 1) patient identifier # (b)(6) evis exera iii duodenovideoscope tjf-q190v, sn (b)(6) (this report).2) patient identifier # (b)(6) evis exera iii duodenovideoscope tjf-q190v sn -unk.
 
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Brand Name
EVIS EXERA III DUODENOVIDEOSCOPE
Type of Device
DUODENOVIDEOSCOPE
Manufacturer (Section D)
AIZU OLYMPUS CO., LTD.
3-1-1 niiderakita
aizuwakamatsu-shi, fukushima 965-8 520
JA  965-8520
MDR Report Key18489927
MDR Text Key332604574
Report Number2429304-2024-00017
Device Sequence Number1
Product Code FDT
UDI-Device Identifier04953170405563
UDI-Public04953170405563
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/11/2023,01/10/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberTJF-Q190V
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date12/11/2023
Device Age3 YR
Event Location Hospital
Date Report to Manufacturer12/11/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/10/2024
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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