MAUDE Adverse Event Report: MEDIGUS LTD MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER SYSTEM MUSE; ENDSTAPLER

Model Number	MUSE ENDOSTAPLER
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Pleural Effusion (2010)
Date of Event	04/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The endostapler functioned as expected during the entire procedure.A review of manufacturing, device history, and quality control records found that the device met all specifications and was in compliance.There were no findings to suggest that the device caused or contributed in any way to the patient's injury.
Event or Problem Description
The fundoplication procedure was done on (b)(6).The next day, the medigus representative learned that, several hours after the procedure, the female patient had severe chest pain.The ct scan was abnormal, indicating pleural effusion, pneumomediastinum and an esophageal perforation of 1 cm.Laparoscopic surgery was done to repair the perforation.Patient was stable twelve hours after surgery.

• Brand Name: MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER SYSTEM MUSE
• Common Device Name: ENDSTAPLER
• Manufacturer (Section D): MEDIGUS LTD; 7a industrial park; pob 3030; omer, israel 84965 ; IS 84965
• MDR Report Key: 7532326
• Report Number: 3004444684-2018-00002
• Device Sequence Number: 19245657
• Product Code: ODE
• UDI-Device Identifier: 07290014036062
• UDI-Public: 07290014036062
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K132151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/25/2018

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: Physician
• Device Expiration Date: 09/30/2018
• Device Model Number: MUSE ENDOSTAPLER
• Device Catalogue Number: MEMA1010005
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2018
• Initial Report FDA Received Date: 05/22/2018
• 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; Required Intervention
• Patient Age: 37 YR