MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-05-25 for MUSE - MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER SRS05 MMAA1006002 manufactured by Medigus, Ltd..
[45958556]
Device performed as intended. No malfunction or defect of device noted. (b)(4). Manufacturer: medigus ltd (b)(4). Importer: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[45958557]
A muse endoscopic procedure for the treatment of gerd was successfully completed. The next day, the patient developed a fever. He was treated with antibiotics (metronidazole) for three more days but the fever did not resolve. A chest x ray showed mild pneumomediastinum. An abdominal and chest ct scan done on the fourth day showed bilateral pleural effusion, atelectasis, mediastinitis and a leakage of contrast substance to the mediastinum. An endoscopy was performed but revealed no perforation. On the fifth day post procedure, the patient had a bilateral chest tube insertion to drain the pleural effusion and a laparoscopic procedure during which a small perforation was identified. The surgeon noticed that pus was draining from the perforation due to mediastinum abscess. He drained the mediastinal abscess, then sutured and patched the esophageal perforation. Patient improved clinically after the procedures and fever subsided. As of last clinical update on (b)(6), the patient was doing fine, had no fever and white blood cell count was in normal range. Conclusion: mediastinal abscess due to esophageal perforation. Stapling of diaphragm cruses created tension that led to perforation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004444684-2016-00003 |
| MDR Report Key | 5680490 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-05-25 |
| Date of Report | 2016-04-29 |
| Date of Event | 2016-04-21 |
| Date Facility Aware | 2016-04-29 |
| Date Mfgr Received | 2016-04-29 |
| Device Manufacturer Date | 2015-06-11 |
| Date Added to Maude | 2016-05-25 |
| 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 |
| Remedial Action | PM |
| 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 | 2016-05-25 |
| Model Number | SRS05 |
| Catalog Number | MMAA1006002 |
| Device Expiration Date | 2016-06-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 10 MO |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-05-25 |