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 2017-07-19 for MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER SYSTEM MUSE SRS05 MMAA1006004 manufactured by Medigus Ltd.
[80453294]
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.
Patient Sequence No: 1, Text Type: N, H10
[80453295]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004444684-2017-00003 |
| MDR Report Key | 6725212 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-07-19 |
| Date of Report | 2017-06-25 |
| Date of Event | 2017-06-25 |
| Date Mfgr Received | 2017-06-25 |
| Device Manufacturer Date | 2016-02-06 |
| Date Added to Maude | 2017-07-19 |
| 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 POB 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 | 2017-07-19 |
| Model Number | SRS05 |
| Catalog Number | MMAA1006004 |
| Device Expiration Date | 2018-02-28 |
| 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, ISRAEL 84965 IS 84965 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2017-07-19 |