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	03/13/2018
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.
Event or Problem Description
The patient is an active (b)(6) year old woman in general good health except as noted in "other relevant history." the procedure was uneventful.On the day after the procedure, she complained of shortness of breath and retrosternal pain.There were no clinical signs of an inflammatory response but a ct scan disclosed small pneumomediastinum and pleural effusion.A chest drain was placed and a small amount of clear fluid was drained.The fluid was a transudate (protein<3).The chest drain was removed on day two and there was no radiological evidence of continuing leakage.Although the chest pain resolved, the patient continued to complain of epigastric pain and was found to have a new duodenal ulcer for which she is now receiving treatment.The patient may have developed the ulcer because she stopped taking the ppi since she no longer had gerd symptoms.The event was deemed as procedure related rather than device related by the medical director for the hospital.Also, due to the high prevalence of h.Pylori contamination in (b)(6), screening for h.Pylori colonization before the procedure was strongly recommended.The procedure can be done after eradication of h.Pylori.

• 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: 7430689
• Report Number: 3004444684-2018-00001
• Device Sequence Number: 16425173
• 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): 03/18/2018

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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2018
• Initial Report FDA Received Date: 04/13/2018
• 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: 80 YR
• Patient Weight: 52