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U.S. Department of Health and Human Services

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

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AIZU OLYMPUS CO., LTD. EVIS EXERA II DUODENOVIDEOSCOPE Back to Search Results
Model Number TJF-Q180V
Device Problem Microbial Contamination of Device (2303)
Patient Problem Bacterial Infection (1735)
Event Type  Injury  
Manufacturer Narrative
D1.The customer was unable to provide the model and serial number for the scope involved.A representative product code and legal manufacturer was selected based on related complaints.The device referenced in this report was not returned to olympus for evaluation.The root cause cannot be determined at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
 
Event Description
A user facility reported to olympus that there was a concern for infection on the repair request.Upon follow up, it was stated that 11 patient's at the facility were infected with pseudomonas aeruginosa 4 mrgn vim positive.The facility did not have any specifics regarding the patient's and when the procedures occurred, or any other infection details.It was only stated that all 11 patients had procedures between (b)(6)2022 and (b)(6) 2022 with the last detection of the micro-organism in march 2023.It was stated that it became clear to the facility in (b)(6) 2023 that the scope was the cause for infection.The entire cleaning process had been reviewed by local regulatory authorities, including the cleaning machines, and it was found that the reprocessing was adequate.The following outcomes were reported: three of the 11 patients have since died.The facility has clearly communicated that the infection was not the cause of death, but rather, their pre-existing conditions.Eight of the 11 patients are "doing well." one of these eight patients was placed on the liver transplant list after the infection.The facility refused to clarify if it was directly due to the infection or not.As there are 11 total patients, the patient identifiers are as follows: (b)(6).This mdr is for patient identifier (b)(6).
 
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Brand Name
EVIS EXERA II 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
Manufacturer (Section G)
AIZU OLYMPUS CO., LTD.
3-1-1 niiderakita
aizuwakamatsu-shi, fukushima
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key16996540
MDR Text Key315911753
Report Number9610595-2023-07986
Device Sequence Number1
Product Code FDT
UDI-Device Identifier04953170367311
UDI-Public04953170367311
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K143153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberTJF-Q180V
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/22/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/30/2017
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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