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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 Type  malfunction  
Event Description
It was reported, the connecting tube could not be connected to the channel connector.The issue occurred during reprocessing.There were no reports of patient harm.
 
Manufacturer Narrative
The customer's allegation was confirmed.The device evaluation found the lock levers on the reprocessor side connector were broken.Based on the results of the investigation, it is likely that the following led to the malfunction: external stress, such as user applied force in an incorrect direction, was applied to lock levers of the connecting tube, which broke the lever and the tube was unable to be connected.However, a definitive root cause cannot be identified.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.This issue is addressed in the instructions for use (ifu): "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 the field performance of this device.Should additional relevant information become available, a supplemental report will be submitted.
 
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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 965-8 520
JA   965-8520
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key18937475
MDR Text Key338986549
Report Number9610595-2024-05859
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,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/19/2024
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 NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2024
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/17/2023
Initial Date FDA Received03/19/2024
Was Device Evaluated by Manufacturer? Yes
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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