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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 04/11/2023
Event Type  Injury  
Event Description
The customer reported to olympus that the single use distal cover came off from the evis exera iii duodenovideoscope.The issue was found at the end of a therapeutic, endoscopic retrograde cholangiopancreatography (ercp) which was completed using the same equipment.The cover was retrieved by the doctor at the time of the event.The procedure was extended for an unspecified amount of time during the search of the cap.There were no reports of patient harm.This event is reported under the following patient identifiers: (b)(6) - evis exera iii duodenovideoscope.(b)(6) - single use distal cover.
 
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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 Key16910971
MDR Text Key314995639
Report Number2429304-2023-00091
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 04/11/2023,05/11/2023
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? Yes
Distributor Facility Aware Date04/11/2023
Event Location Hospital
Date Report to Manufacturer04/11/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/11/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MAJ-2315/H228093
Patient Outcome(s) Required Intervention;
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