MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-01-05 for ENDO GIA* TRI-STAPLE RR 45MM M/T RELOAD EGIATRS45AMT manufactured by Covidien, Formerly Us Surgical A Divison.
[63987588]
(b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[63987589]
According to the reporter the procedure performed was a wedge thoraco resection in the right inferior lobe. The primary disease was an interstitial pneumonia and pulmonary cancer. The surgeon did not trim neoveil of the crossing points in the 1st to the 5th staple lines. The surgeon trimmed the excess neoveil which did not cover the tissue, at the point of 5mm from the last cut end of the tissue. There was no problem during and after surgery. There was no problem with the surgical instruments during the surgery. The patient stood up in the rehabilitation on the first postoperative day. After that, there was low blood pressure and an emergency re-operation was performed. There was 4000ml of bleeding at thoracotomy incision and bleeding at intercostal artery. The drain was indwelled at the thoracotomy incision since the first surgery. They took the surgical instruments in and out from this thoracotomy incision. They corrected the bleeding during the reoperation with an electrosurgical knife and put a tachosil on it. The patient lost most of the eyesight after awaking from the re-operation. The patient could only see the brightness of the light. The event occurred/was noticed after the surgery. Reoperation was required due to the issue. More than 500 cc of bleeding occurred as a result of the issue. The patient received blood transfusion as a result of the issue. The surgical time was approximate 1 hour. Currently, the patient still has little vision and can only see thebrightness of the light. The surgeon estimates the cause of the patient? S visual loss after the emergency re-operation is ischemic optic neuropathy. Additional tissue resection was not required. There was no tissue damage. Nothing fell into the patient's cavity.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219930-2017-00020 |
| MDR Report Key | 6226893 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-01-05 |
| Date of Report | 2016-12-08 |
| Date of Event | 2016-12-02 |
| Date Mfgr Received | 2016-12-08 |
| Date Added to Maude | 2017-01-05 |
| 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 | SHARON MURPHY |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer G1 | COVIDIEN, FORMERLY US SURGICAL A DIVISON |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06473 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDO GIA* TRI-STAPLE RR 45MM M/T RELOAD |
| Generic Name | MESH, SURGICAL, DEPLOYER |
| Product Code | ORQ |
| Date Received | 2017-01-05 |
| Model Number | EGIATRS45AMT |
| Catalog Number | EGIATRS45AMT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN, FORMERLY US SURGICAL A DIVISON |
| Manufacturer Address | 60 MIDDLETOWN AVE NORTH HAVEN CT 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention; 4. Deathisabilit | 2017-01-05 |