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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 Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/30/2023
Event Type  Injury  
Manufacturer Narrative
The suspect device has not been returned to olympus.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.This report has also been submitted on importer medwatch report #2429304 - 2023 - 00163.
 
Event Description
The customer reported to olympus that the single use distal cover fell off from the evis exera iii duodenovideoscope during a therapeutic endoscopic retrograde cholangiopancreatography (ercp) procedure.An esophagogastroduodenoscopy (egd) was performed to see if the distal cover was retained in the patient's gastrointestinal tract.After both the ercp and egd were completed, the distal cover was found in the patient's mouth.The procedure was prolonged by 5 minutes with the patient under anesthesia.The distal cover was disposed after the procedure.The operator felt that the distal cover had been placed correctly without resistance or difficulty and that he felt the cover "snap" into place.The operator further felt that there were no errors in placing the device.There was no harm or user injury reported due to the event.This event is reported under the following patient identifiers: (b)(6)- evis exera iii duodenovideoscope.(b)(6)- single use distal cover.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 year since the subject device was manufactured.Based on the results of the investigation, it is likely that the cover easily came off the subject scope due to insufficient attachment (refer to capa-200735).However, the root cause could not be determined.The event can be detected/prevented by following the instructions for use (ifu) in sections: ¿operation manual includes the detection way at chapter 4 - 4.1.¿ ¿operation manual includes the preventive measures at chapter 3 - 3.5.¿ this supplemental report includes information added to d8.Also, a correction has been made to e4.Olympus will continue to monitor field performance for this device.
 
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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
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 Key17054270
MDR Text Key316481563
Report Number9610595-2023-08342
Device Sequence Number1
Product Code FDT
UDI-Device Identifier04953170405563
UDI-Public04953170405563
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K220587
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 06/19/2023
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? No
Initial Date Manufacturer Received 05/04/2023
Initial Date FDA Received06/02/2023
Supplement Dates Manufacturer Received06/14/2023
Supplement Dates FDA Received06/19/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/30/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
MAJ-2315 / LOT NUMBER H2713.
Patient Outcome(s) Required Intervention;
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