MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-03-01 for AIR HOSE 3.0M AESC.-DRAEGER/AESC.SMALL GA513R manufactured by Aesculap Ag.
[137524530]
(b)(4). When additional information is received a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[137524531]
It was reported by the healthcare professional that the io tube exploded. During the surgical procedure of dr. (b)(6), the surgeon heard a loud noise after a strong pressure on the drill pen (motor), where it moved laterally, injuring the patient's left internal carotid artery. After that, the drill did not work any more and it was noticed that the hose was damaged, with abundant air outlet in its distal portion, near the pen, pretending to have exploded. "was used the drill medially to the left carotid artery. The drill was working normally when uphill it was heard a loud noise coming from the pneumatic drill hose, with strong pressure on the pen, which moved laterally, injuring the left carotid artery. " "we controlled the massive bleeding of the internal carotid artery on the left. The patient underwent arteriography, which showed occlusion of the left internal carotid artery. Performed decompensated craniectomy, to reduce risk of cerebral herniation, but the patient evolved with significant cerebral squamism, and evolved to brain death. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00152 |
| MDR Report Key | 8381731 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-03-01 |
| Date of Report | 2019-07-31 |
| Date of Event | 2019-01-23 |
| Date Facility Aware | 2019-04-15 |
| Date Mfgr Received | 2019-07-18 |
| Device Manufacturer Date | 2016-06-15 |
| Date Added to Maude | 2019-03-01 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KERSTIN ROTHWEILER |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, PA 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78501 |
| Manufacturer G1 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIR HOSE 3.0M AESC.-DRAEGER/AESC.SMALL |
| Generic Name | HIGHSPEED POWER SYSTEMS |
| Product Code | GET |
| Date Received | 2019-03-01 |
| Model Number | GA513R |
| Catalog Number | GA513R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Life Threatening | 2019-03-01 |