MAUDE Adverse Event Report: LUMENDI LLC DILUMEN ENDOLUMENAL INVERVENTIONAL PLATFORM; ENDOSCOPE ACCESORY

Model Number	159-19758-01
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	06/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
A (b)(6) male with a history of severe sigmoid diverticulosis underwent colonoscopy with an olympus pediatric colonoscope and the dilumen device on (b)(6) 2018.During navigation, resistance to intubation was encountered on the left side of the colon due to tortuous anatomy.During continued advancement, the scope bowed downstream of the scope tip at the level of the sigmoid, causing a perforation in the sigmoid.The device and scope were removed.An endolumenal suturing device was then used to close the defect and the patient was admitted.Patient experienced some abdominal pain on (b)(6) and ct scan suggested possible peritonitis.An exploratory laparotomy was done on (b)(6) 2018.There was no peritonitis, but one stitch did not close the colon defect completely and the patient underwent a sigmoid colectomy.The patient was discharged to home on (b)(6) 2018.Examination of the dilumen device by the manufacturer revealed no deviation of device specifications and no evidence of device failure.

• Brand Name: DILUMEN ENDOLUMENAL INVERVENTIONAL PLATFORM
• Common Device Name: ENDOSCOPE ACCESORY
• Manufacturer (Section D): LUMENDI LLC; 253 post road west; westport CT 06880
• MDR Report Key: 7667244
• Report Number: 3013505983-2018-00001
• Device Sequence Number: 1980190
• Product Code: FDF
• UDI-Device Identifier: 00865309000232
• UDI-Public: 00865309000232
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K162428
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/06/2018

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: 03/16/2019
• Device Model Number: 159-19758-01
• Device Catalogue Number: D-1001
• Device Lot Number: 75CH1610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2018
• Initial Report FDA Received Date: 07/06/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 74 YR