MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-17 for MEDTRONIC PITUITARY RONGUER 9569536 manufactured by Medtronic.
[97714591]
Physician was using a pituitary rongeur, and the grabber piece broke off, the tip into the patient's back and physician was unable to retrieve. It is between bone and ligament. Not safe to poke around without getting into a life threatening situation. There is no concern about migration.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074649 |
| MDR Report Key | 7202996 |
| Date Received | 2018-01-17 |
| Date of Report | 2018-01-16 |
| Date of Event | 2018-01-10 |
| Date Added to Maude | 2018-01-18 |
| 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 | MEDTRONIC PITUITARY RONGUER |
| Generic Name | PITUITARY RONGUER |
| Product Code | HAO |
| Date Received | 2018-01-17 |
| Model Number | 9569536 |
| Lot Number | CE0123 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-17 |