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

Model Number	SRS05
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930)
Date of Event	06/05/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The first day after surgery ((b)(6) 2017), the patient had throat discomfort, with a slight discomfort of substernal esophagus and middle & upper abdominal region.There was no fever or abdominal pain but since her blood leucocytes were high, she was placed on an intravenous infusion of cefazolin for anti-infection treatment.Later, the patient did have a fever, the highest temperature being 38.3 degrees celsius.The symptoms were marked by throat pain with a slight discomfort in the posterior esophagus and the middle and upper abdomen and fatigue.The patient refused to have a chest and abdominal ct done to determine the reason for the symptoms so the hospital continued the antibiotics, anti-inflammatory drugs treatment, and ppi drugs to protect the stomach.The fever lasted for more than three days; then the body temperature returned to normal and the symptoms gradually disappeared.On the sixth day ((b)(6)), the blood tests were normal.The patient remained on intravenous antibiotics for another two days and then was discharged on (b)(6) 2017.

• Brand Name: MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER SYSTEM MUSE
• Common Device Name: ENDOSCOPE
• Manufacturer (Section D): MEDIGUS LTD; 7a industrial park; pob 3030; omer, 84965 ; IS 84965
• MDR Report Key: 6677619
• Report Number: 3004444684-2017-00001
• Device Sequence Number: 13470866
• Product Code: ODE
• UDI-Device Identifier: 07290014036062
• UDI-Public: 07290014036062
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/07/2017

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: 02/06/2018
• Device Model Number: SRS05
• Device Catalogue Number: MMAA1006004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2017
• Initial Report FDA Received Date: 06/29/2017
• 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; Other
• Patient Age: 50 YR
• Patient Weight: 80