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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 Problems Crack (1135); Material Separation (1562); Failure to Clean Adequately (4048)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
The device inspection found white foreign material inside the air/water tube and cylinder.The adhesive at the distal end was cracked and had a gap.There was foreign material in the light guide lens.Foreign material was also found beneath the forceps elevator.
 
Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
 
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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 965-8 520
JA   965-8520
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key19004375
MDR Text Key339087165
Report Number9610595-2024-06663
Device Sequence Number1
Product Code FDT
UDI-Device Identifier04953170367311
UDI-Public04953170367311
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K143153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberTJF-Q180V
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/14/2024
Was the Report Sent to FDA? No
Date Manufacturer Received03/20/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/06/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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