MAUDE Adverse Event Report: LUMENDI, LLC DILUMEN ENDOLUMENAL INTERVENTIONAL PLATFORM

Model Number	DILUMEN 130 CM
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Patient had a 3 cm lesion in the ascending colon.Patient had a very tortuous anatomy and the doctor had difficulty navigating to the lesion site.He was able to see the lesion in the endoscopic view.When he had trouble going any further, he started to manipulate the dilumen fore balloon by trying to extend it past the lesion.He was unable to get past the lesion and pulled the device out and that is when we saw the push rod on the left became separated.The case was finished with only the adult pentax colonoscope and the patient was discharged that same day.No adverse event.

• Brand Name: DILUMEN ENDOLUMENAL INTERVENTIONAL PLATFORM
• Common Device Name: DILUMEN
• Manufacturer (Section D): LUMENDI, LLC; 253 post road west; westport CT 06880
• MDR Report Key: 12363020
• Report Number: 3013505983-2021-00002
• Device Sequence Number: 3516005
• Product Code: FDF
• UDI-Device Identifier: 00865309000225
• UDI-Public: 00865309000225
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K210851
• Number of Events Summarized: 1
• 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): 08/23/2021

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 Date: 05/19/2023
• Device Model Number: DILUMEN 130 CM
• Device Catalogue Number: D-1001
• Device Lot Number: 75DA9129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1