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 2018-05-22 for MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER SYSTEM MUSE MUSE ENDOSTAPLER MEMA1010005 manufactured by Medigus Ltd.
[108851145]
The endostapler functioned as expected during the entire procedure. A review of manufacturing, device history, and quality control records found that the device met all specifications and was in compliance. There were no findings to suggest that the device caused or contributed in any way to the patient's injury.
Patient Sequence No: 1, Text Type: N, H10
[108851146]
The fundoplication procedure was done on (b)(6). The next day, the medigus representative learned that, several hours after the procedure, the female patient had severe chest pain. The ct scan was abnormal, indicating pleural effusion, pneumomediastinum and an esophageal perforation of 1 cm. Laparoscopic surgery was done to repair the perforation. Patient was stable twelve hours after surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004444684-2018-00002 |
| MDR Report Key | 7532326 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-05-22 |
| Date of Report | 2018-04-25 |
| Date of Event | 2018-04-25 |
| Date Mfgr Received | 2018-04-25 |
| Device Manufacturer Date | 2018-04-08 |
| Date Added to Maude | 2018-05-22 |
| 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 | 2018-05-22 |
| Model Number | MUSE ENDOSTAPLER |
| Catalog Number | MEMA1010005 |
| Device Expiration Date | 2018-09-30 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-05-22 |