MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-12 for MICRO PITUITARY RONGEUR CT # NL 6250 manufactured by Codman.
[38531846]
Micro pituitary rongeur prong chipped during surgical procedure on patient's spine, sending small metal piece into surgical field. Diagnosis or reason for use: removal of loose bone fragments. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5060257 |
| MDR Report Key | 5445183 |
| Date Received | 2016-02-12 |
| Date of Report | 2016-02-12 |
| Date of Event | 2016-02-08 |
| Date Added to Maude | 2016-02-18 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | MICRO PITUITARY RONGEUR CT # NL 6250 |
| Generic Name | MICRO PITUITARY RONGEUR CT # NL 6250 |
| Product Code | EMH |
| Date Received | 2016-02-12 |
| Model Number | MICRO PITUITARY RONGEUR |
| Catalog Number | # NL 6250 |
| ID Number | NL 6250 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-02-12 |