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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. GASTROINTESTINAL VIDEOSCOPE
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AIZU OLYMPUS CO., LTD. GASTROINTESTINAL VIDEOSCOPE Back to Search Results
Model Number GIF-XZ1200
Device Problem Device Reprocessing Problem (1091)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/26/2024
Event Type  malfunction  
Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
During the device evaluation, the gastrointestinal videoscope exhibited foreign matter adhered to the surface of the objective lens.There were no reports of patient involvement.
 
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Brand Name
GASTROINTESTINAL VIDEOSCOPE
Type of Device
GASTROINTESTINAL VIDEOSCOPE
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 Key19198681
MDR Text Key341512097
Report Number9610595-2024-08808
Device Sequence Number1
Product Code FDS
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/26/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberGIF-XZ1200
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/23/2024
Was the Report Sent to FDA? No
Date Manufacturer Received04/26/2024
Was Device Evaluated by Manufacturer? No
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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