MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-06-29 for MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER SYSTEM MUSE SRS05 MMAA1006004 manufactured by Medigus Ltd.
[78723238]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004444684-2017-00001 |
| MDR Report Key | 6677619 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-06-29 |
| Date of Report | 2017-06-07 |
| Date of Event | 2017-06-05 |
| Date Mfgr Received | 2017-06-07 |
| Device Manufacturer Date | 2016-02-06 |
| Date Added to Maude | 2017-06-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR RONEN COHEN |
| Manufacturer Street | 7A INDUSTRIAL PARK P.O.B. 3030 |
| Manufacturer City | OMER, ISRAEL 84965 |
| Manufacturer Country | IS |
| Manufacturer Postal | 84965 |
| Manufacturer G1 | MEDIGUS LTD |
| Manufacturer Street | 7A INDUSTRIAL PARK POB 3030 |
| Manufacturer City | OMER, ISRAEL 84965 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 84965 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER SYSTEM MUSE |
| Generic Name | ENDOSCOPE |
| Product Code | ODE |
| Date Received | 2017-06-29 |
| Model Number | SRS05 |
| Catalog Number | MMAA1006004 |
| Device Expiration Date | 2018-02-06 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIGUS LTD |
| Manufacturer Address | 7A INDUSTRIAL PARK POB 3030 OMER, 84965 IS 84965 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2017-06-29 |