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 2015-12-07 for MUSE - MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER SRS05 MMAA10060000 manufactured by Medigus, Ltd..
[32858020]
Event occurred in (b)(6). Device performed as intended; no malfunction or defect of device noted at time of procedure. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[32858021]
After the first stapling was completed during an endoscopic fundoplication procedure with the muse device, an inspection was conducted with a standard gastroscope. A small gastric perforation was noted. The perforation was closed endoscopically. Per the attending physician, the subject suffered no additional ill effects and recovered uneventfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004444684-2015-00002 |
| MDR Report Key | 5272355 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-12-07 |
| Date of Report | 2015-11-09 |
| Date of Event | 2015-11-09 |
| Date Facility Aware | 2015-11-10 |
| Date Mfgr Received | 2015-11-09 |
| Device Manufacturer Date | 2015-07-02 |
| Date Added to Maude | 2015-12-07 |
| 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 | MEDIGUS LTD. |
| Manufacturer Street | 7A INDUSTRIAL PARK PO BOX 3030 |
| Manufacturer City | OMER,, ISRAEL 8496500 |
| Manufacturer Country | IS |
| Manufacturer Postal | 8496500 |
| Manufacturer Phone | 86466880 |
| Manufacturer G1 | MEDIGUS, LTD. |
| Manufacturer Street | SUITE 7A INDUSTRIAL PARK POB 3030 |
| Manufacturer City | OMER, ISRAEL 8496500 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 8496500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MUSE - MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER |
| Generic Name | ENDOSTAPLER |
| Product Code | ODE |
| Date Received | 2015-12-07 |
| Model Number | SRS05 |
| Catalog Number | MMAA10060000 |
| Device Expiration Date | 2016-07-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIGUS, LTD. |
| Manufacturer Address | SUITE 7A INDUSTRIAL PARK POB 3030 OMER, ISRAEL 8496500 IS 8496500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-12-07 |