MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-12 for KERRISON manufactured by Aesculap.
[94811435]
Neurosurgeon was using the number three kerrison instrument during a surgical procedure, a screw came loose on the kerrison and fell into the spinal cord. Neurosurgeon had to dig around in the opening with the suction and cst used a forcep to quickly grab it before it went into the neptune. No harm was done to the pt and instrument was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073932 |
| MDR Report Key | 7112090 |
| Date Received | 2017-12-12 |
| Date of Report | 2017-12-11 |
| Date of Event | 2017-12-08 |
| Date Added to Maude | 2017-12-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | KERRISON |
| Generic Name | RONGEUR, POWERED |
| Product Code | HAD |
| Date Received | 2017-12-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-12-12 |