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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 Problems Device Reprocessing Problem (1091); Failure to Clean Adequately (4048)
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.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and 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 (3) years since the subject device was manufactured.The legal manufacturer confirmed that the customer's reprocessing steps were in accordance with the instructions for use: based on the results of the investigation, olympus confirmed that foreign material remained on the objective lens, component analysis revealed that the foreign material was a mixture of drug-derived organic silicone and silicic acid and a mixture of human-derived protein and sodium chloride.There was no physical damage to the location of the foreign material.The cause of the material remaining in the device could not be determined.Olympus confirmed that the inspection method for this event is described in the reprocessing manual "chapter 5, section 5.5 manual cleaning of endoscopes and accessories" and "chapter 8 storage and disposal," especially when reprocessing air and water supply.Confirm that stain has been removed from the nozzle opening and objective lens surface.If the stain remains, clean until all of the stain is removed, rinse thoroughly, and remove any residue in the channel after cleaning.Please check the handling environment, such as draining water and drying.Olympus will continue to monitor field performance for this device.
 
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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
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,Followup
Report Date 05/30/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 04/26/2024
Initial Date FDA Received04/26/2024
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/30/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/22/2021
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
CV-1500 VIDEO SYSTEM CENTER
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