MAUDE Adverse Event Report: LUMENDI LLC DILUMEN ENDOLUMENAL INTERVENTIONAL PLATFORM

Model Number	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	06/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Perforation of the bowel is a known risk during endoscopic exams and interventions.
Event or Problem Description
Perforation of recto-sigmoid colon.Patient- (b)(6)-year-old, female with a tortuous colon and a fixed sigmoid colon due to previous oophorectomy and appendectomy.The endoscope and dilumen entered the anus and the doctor proceeded to introduce the endoscope/dilumen through the rectum and up into the sigmoid.Approx.8 minutes later bleeding would be seen at the anus.After removing both dilumen and the scope, the scope was reinserted without dilumen, and a perforation (approximately 4 cm) was discovered in the area of the recto-sigmoid colon.The perforation was closed endoscopically and confirmed under fluoroscopy.There was no further sequelae from the incident.The attending doctor indicated that it was likely that aggressive navigation of the endoscope/device in a narrow and fixed sigmoid patient's anatomy caused the perforation and was not specifically device related.

• 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: 12125374
• Report Number: 3013505983-2021-00001
• Device Sequence Number: 11956307
• Product Code: FDF
• UDI-Device Identifier: 00865309000225
• UDI-Public: 00865309000225
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/06/2021

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 Model Number: 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: 06/11/2021
• Initial Report FDA Received Date: 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR