MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-04-13 for MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER SYSTEM MUSE MUSE ENDOSTAPLER MEMA1010005 manufactured by Medigus Ltd.
[105507054]
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.
Patient Sequence No: 1, Text Type: N, H10
[105507055]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004444684-2018-00001 |
| MDR Report Key | 7430689 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-04-13 |
| Date of Report | 2018-03-18 |
| Date of Event | 2018-03-13 |
| Date Mfgr Received | 2018-03-18 |
| Device Manufacturer Date | 2018-02-19 |
| Date Added to Maude | 2018-04-13 |
| 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 | ENDSTAPLER |
| Product Code | ODE |
| Date Received | 2018-04-13 |
| Model Number | MUSE ENDOSTAPLER |
| Catalog Number | MEMA1010005 |
| Device Expiration Date | 2018-09-30 |
| 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 | 2018-04-13 |