MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-04-27 for NEUROPEN UNKNOWN-ES manufactured by Medtronic Neurosurgery.
[73892512]
The product was unavailable for return. Therefore an evaluation of the device performance was not possible. A review of the manufacturing records was not possible as no lot number was provided. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[73892513]
It was reported to medtronic neurosurgery that the physician connected a light cable to the system that was not from the manufacturer. According to the report, the connection of the light source caused the device to heat and produce smoke. Reportedly, the case was aborted.
Patient Sequence No: 1, Text Type: D, B5
[94227679]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021898-2017-00233 |
| MDR Report Key | 6528155 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-04-27 |
| Date of Report | 2017-03-28 |
| Date Mfgr Received | 2017-03-28 |
| Date Added to Maude | 2017-04-27 |
| 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 | BOB SHOKOOHI |
| Manufacturer Street | 125 CREMONA DRIVE |
| Manufacturer City | GOLETA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal | 93117 |
| Manufacturer Phone | 8055718725 |
| Manufacturer G1 | MEDTRONIC NEUROSURGERY |
| Manufacturer Street | 125 CREMONA DRIVE |
| Manufacturer City | GOLETA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93117 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUROPEN |
| Generic Name | ENDOSCOPE, NEUROLOGICAL |
| Product Code | GWG |
| Date Received | 2017-04-27 |
| Catalog Number | UNKNOWN-ES |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROSURGERY |
| Manufacturer Address | 125 CREMONA DRIVE GOLETA CA 93117 US 93117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-27 |