MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-12-13 for MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER SYSTEM MUSE SRS05 MMAA10060000 manufactured by Medigus Ltd.
[62267382]
(b)(4). This mdr was originally submitted on december 9, 2016, but it was not accepted because it was submitted as an xml file instead of a zip file.
Patient Sequence No: 1, Text Type: N, H10
[62267383]
It was brought to our attention that on (b)(6) 2016, during the preparation stage for a muse procedure and after the insertion of the overtube, the physician noticed a possible laceration of the esophageal wall. The physician decided to place a stent. The muse procedure was cancelled and the endostapler was discarded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004444684-2016-00004 |
| MDR Report Key | 6170928 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-12-13 |
| Date of Report | 2016-11-14 |
| Date of Event | 2016-11-08 |
| Date Facility Aware | 2016-11-14 |
| Date Mfgr Received | 2016-11-14 |
| Device Manufacturer Date | 2016-06-13 |
| Date Added to Maude | 2016-12-13 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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, 84965 |
| Manufacturer Country | IS |
| Manufacturer Postal | 84965 |
| Manufacturer Phone | 9725435163 |
| Manufacturer G1 | MEDIGUS LTD. |
| Manufacturer Street | 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 | MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER SYSTEM MUSE |
| Generic Name | ENDOSTAPLER |
| Product Code | ODE |
| Date Received | 2016-12-13 |
| Model Number | SRS05 |
| Catalog Number | MMAA10060000 |
| Device Expiration Date | 2018-05-25 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 5 MO |
| 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 8496500 IS 8496500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-12-13 |