MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-12 for V. MUELLER LOVE-GRUENWALD PITUITARY FORCEPS 2X10MM NL6146 manufactured by Carefusion 2200, Inc.
[178786221]
The jaws of the narrow pituitary, out of the neuro ronguer set 002, broke while operating inside the disc space. Per the scrub tech, the instrument was not damaged or bent prior to dr. Using it. Surgery was prolonged while trying to retrieve the broken piece of the instrument. The broken piece was successfully removed from the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9699244 |
| MDR Report Key | 9699244 |
| Date Received | 2020-02-12 |
| Date of Report | 2020-01-31 |
| Date of Event | 2020-01-27 |
| Report Date | 2020-01-31 |
| Date Reported to FDA | 2020-01-31 |
| Date Reported to Mfgr | 2020-02-12 |
| Date Added to Maude | 2020-02-12 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Brand Name | V. MUELLER LOVE-GRUENWALD PITUITARY FORCEPS 2X10MM |
| Generic Name | RONGEUR, MANUAL |
| Product Code | HAE |
| Date Received | 2020-02-12 |
| Model Number | NL6146 |
| Catalog Number | NL6146 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION 2200, INC |
| Manufacturer Address | 5 SUNNEN DR SAINT LOUIS MO 63143 US 63143 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-12 |