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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: Olympus Vietnam Co. Ltd. SINGLE USE LIGATING DEVICE
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Olympus Vietnam Co. Ltd. SINGLE USE LIGATING DEVICE Back to Search Results
Model Number HX-400U-30
Medical Device Problem Codes Break (1069); Separation Problem (4043)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/26/2026
Type of Reportable Event Malfunction
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Brand Name
SINGLE USE LIGATING DEVICE
Common Device Name
SINGLE USE LIGATING DEVICE
Manufacturer (Section D)
Olympus Vietnam Co. Ltd.
8 street, long thanh ind. zone
an phuoc commune
dong nai province 81000 0
VM  810000
Manufacturer (Section G)
Olympus Vietnam Co. Ltd.
8 street, long thanh ind. zone
an phuoc commune
dong nai province 81000 0
VM   810000
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
+1(508)207-7661
MDR Report Key50797005
Report Number3008040402-2026-00312
Device Sequence Number10515924
Product Code MND
UDI-Device Identifier04953170368615
UDI-Public04953170368615
Combination Product (Y/N)N
Initial Reporter CountryNL
PMA/510(K) Number
CLASS2-EXMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source Foreign,Health Professional,User Facility
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 09/16/2026
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
Operator of Device Health Professional
Device Model NumberHX-400U-30
Device Lot Number63V
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer09/08/2026
Is the Reporter a Health Professional? Yes
Initial Date Received by Manufacturer 08/27/2026
Initial Report FDA Received Date09/16/2026
Was Device Evaluated by Manufacturer? (Y/N) No
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Patient SexUnknown
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