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	Chest Pain (1776); Fever (1858); Pleural Effusion (2010)
Date of Event	06/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the device was not returned, no conclusion can be made regarding whether the device contributed to the event.However, a review of manufacturing, device history, and quality control records found that the device met all specifications and was in compliance.Based on a review of clinical records, it was not clear what the final diagnosis was or what caused the adverse event.
Event or Problem Description
The first day after the procedure was completed ((b)(6) 2017), the patient complained of sudden chest discomfort and fever (38 degrees celsius.) several tests were done to determine the cause.The chest ct scan showed pneumomediastinum at the lower esophageal region.The patient was treated with nexium (acid suppression drug), avelox (anti-inflammatory drug), sulperazone (intravenous antibiotic) and a nasogastric tube was inserted.During the night of (b)(6), the patient's self-reported discomfort disappeared.The patient had no fever the second day ((b)(6)) and body temperature did not exceed 37.4 degrees.On the third day ((b)(6)), the patient's highest temperature was 38.5 degrees celsius.A second ct scan showed inferior lobe consolidation and bilateral pleural effusion.There was no mediastinal emphysema.On the fourth day ((b)(6)), the patient still had an elevated white blood cell count.On the fifth day ((b)(6)), the patient's body temperature returned to normal.On the sixth day ((b)(6)), the patient had no chest or abdominal discomfort and began eating.He was discharged from the hospital on (b)(6), after eleven days of hospitalization.

• Brand Name: MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER SYSTEM MUSE
• Common Device Name: ENDOSCOPE
• Manufacturer (Section D): MEDIGUS LTD; 7a industrial park; pob 3030; omer, israel 84965 ; IS 84965
• MDR Report Key: 6725212
• Report Number: 3004444684-2017-00003
• Device Sequence Number: 1095404
• 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): 06/25/2017

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: 02/28/2018
• Device Model Number: SRS05
• Device Catalogue Number: MMAA1006004
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2017
• Initial Report FDA Received Date: 07/19/2017
• 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; Required Intervention
• Patient Age: 42 YR
• Patient Weight: 70