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

Model Number	DILUMEN 130 CM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	07/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Following a underwater endoluminal procedure and upon removal of the endoscope with dilumen attached, a 3cm perforation approximately 30-35 cm from the anal verge was noted requiring surgical intervention to repair.The doctor did not allege a device malfunction.

• Brand Name: DILUMEN ENDOLUMENAL INTERVENTIONAL PLATFORM
• Common Device Name: DILUMEN
• Manufacturer (Section D): LUMENDI, LLC; 253 post road west; westport CT 06880
• Manufacturer (Section G): LUMENDI, LLC; 253 post road west; westport CT 06880
• Manufacturer Contact: dennis daniels ; 253 post road west; westport, CT 06880 ; 2034632669
• MDR Report Key: 15139785
• Report Number: 3013505983-2022-00003
• Device Sequence Number: 15284594
• 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): N
• 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): 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: DILUMEN 130 CM
• Device Catalogue Number: D-1001
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2022
• Initial Report FDA Received Date: 08/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male