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	07/31/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Note: this event occured in (b)(6) 2021 but was not reported to lumendi until 11/22/2021.When the new sales manager visited the account, he was informed a patient was readmitted in late (b)(6) 2021 with abdominal pain shortly after esd with the device and was subsequently found to have a perforation on the left side of the colon that required surgical intervention.The user reported at the time of the endoscopic intervention he had difficulty navigating the endoscope through the sigmoid colon as the patient had previous pelvic surgery.

• 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: 13046353
• Report Number: 3013505983-2021-00006
• Device Sequence Number: 17505219
• 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): 12/20/2021

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 Expiration Date: 03/08/2023
• Device Model Number: DILUMEN 130 CM
• Device Catalogue Number: D-1001
• Device Lot Number: 75CA0802
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2021
• 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 Sex: Unknown