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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. CONNECTING TUBE; ENDOSCOPE REPROCESSOR ACCESSORIES

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AIZU OLYMPUS CO., LTD. CONNECTING TUBE; ENDOSCOPE REPROCESSOR ACCESSORIES Back to Search Results
Model Number MAJ-2112
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/08/2024
Event Type  malfunction  
Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported the reprocessor connecting tube couldn't be connected to the channel connector in the reprocessing basin.There were no reports of patient harm.
 
Manufacturer Narrative
This supplemental report is being submitted to provide additional information based on the legal manufacturer's final investigation.The customer's allegation was confirmed.The device evaluation found that the connecting tube was broken.Based on the results of the investigation, a definitive root cause of the reported issue could not be determined.However, it is presumed that external stress was applied to the lock lever of the connecting tube, which broke the lever and the tube was unable to be connected.As a cause of the external stress, the user may have applied force toward incorrect direction.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It was confirmed that the subject item was shipped in accordance with specifications.The event can be detected by conducting the following: preparation and inspection: visually inspect the connecting tube to ensure that there are no cracks, breaks, rips, scratches, attached debris, or other irregularities; move the lock levers of the reprocessor side connector to make sure that they function properly and are not broken.Olympus will continue to monitor field performance for this device.
 
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Brand Name
CONNECTING TUBE
Type of Device
ENDOSCOPE REPROCESSOR ACCESSORIES
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 Key19070742
MDR Text Key339789530
Report Number9610595-2024-07381
Device Sequence Number1
Product Code FEB
UDI-Device Identifier04953170404078
UDI-Public04953170404078
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190969
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 05/22/2024
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 Health Professional
Device Model NumberMAJ-2112
Device Lot Number41A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/03/2024
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/03/2024
Initial Date FDA Received04/09/2024
Supplement Dates Manufacturer Received05/10/2024
Supplement Dates FDA Received05/22/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/26/2024
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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