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

Model Number	MUSE ENDOSTAPLER
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Esophagus (2399)
Date of Event	11/09/2018
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 procedure was done on (b)(6) 2018.The first stapling site was around 4cm from the gastroesophageal junction (gej), the second site was performed close to the lesser curve at around 4cm from the gej also.The third stapling site was performed on the opposite site at around 3cm from the gej.On (b)(6) 2018, the results of a chest and abdominal rx and ct scan indicated that there was a perforation on the second stapling site, and the third stapling site which was on the diaphragm and it was necessary to surgically close the air leakage in the abdomen.

• Brand Name: MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER SYSTEM MUSE
• Common Device Name: ENDOSTAPLER
• Manufacturer (Section D): MEDIGUS LTD; 7a industrial park; pob 3030; omer, 84965 ; IS 84965
• MDR Report Key: 8126859
• Report Number: 3004444684-2018-00003
• Device Sequence Number: 1732803
• Product Code: ODE
• UDI-Device Identifier: 07290014036086
• UDI-Public: (01)07290014036086(17)200208(10)27460
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/09/2018

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: 02/09/2020
• Device Model Number: MUSE ENDOSTAPLER
• Device Catalogue Number: MEMA1010005
• Device Lot Number: 830027
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 12/03/2018
• 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: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 65