MAUDE Adverse Event Report: LUMENDI LLC DILUMEN ENDOLUMENAL INTERVENTIONAL PLATFORM; ENDOSCOPE ACCESSORY

Model Number	159-19758-01
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	08/06/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
During navigation with the scope and the device, a sigmoid perforation occurred which was repaired during the procedure with use of endoscopic sutures.Patient was discharged in two days with no further sequelae.User requested that the incident not be reported as device related.

• Brand Name: DILUMEN ENDOLUMENAL INTERVENTIONAL PLATFORM
• Common Device Name: ENDOSCOPE ACCESSORY
• Manufacturer (Section D): LUMENDI LLC; 253 post road west; westport CT 06880
• MDR Report Key: 7805082
• Report Number: 3013505983-2018-00002
• Device Sequence Number: 19155132
• 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): 08/22/2018

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 08/22/2018
• 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
• Patient Age: 66 YR