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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LUMENDI, LLC DILUMEN ENDOLUMENAL INTERVENTIONAL PLATFORM
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LUMENDI, LLC DILUMEN ENDOLUMENAL INTERVENTIONAL PLATFORM Back to Search Results
Model Number DILUMEN 130 CM
Medical Device Problem Code Mechanical Problem (1384)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 09/16/2021
Type of Reportable Event Malfunction
Event or Problem Description
During polypectomy, doctor noticed migration of device fore balloon and then noticed that the fore balloon was completely separated from device with both push rods broken.Doctor removed dilumen device and then separately went back in with a snare to remove fb and push rod segments.Post-procedure, x ray was done which revealed no perforation of the colon.
 
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Brand Name
DILUMEN ENDOLUMENAL INTERVENTIONAL PLATFORM
Common Device Name
DILUMEN
Manufacturer (Section D)
LUMENDI, LLC
253 post road west
westport CT 06880
MDR Report Key12605859
Report Number3013505983-2021-00005
Device Sequence Number1309571
Product Code FDF
UDI-Device Identifier00865309000225
UDI-Public00865309000225
Combination Product (Y/N)N
Initial Reporter StateCT
Initial Reporter CountryUS
PMA/510(K) Number
K210851
Number of Events Summarized1
Summary Report (Y/N)Y
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/11/2021
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 No Information
Device Expiration Date05/19/2023
Device Model NumberDILUMEN 130 CM
Device Catalogue NumberD-1001
Device Lot Number75DA9129
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/16/2021
Initial Report FDA Received Date10/11/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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