MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-18 for AESCULAP #FF562 N/A manufactured by Aesculap Instruments.
[12185]
During surgery, upper jaw broke from forcep while in the disc space. Broken portion of instrument removed from patient. No harm to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 25209 |
| MDR Report Key | 25209 |
| Date Received | 1995-01-18 |
| Date of Report | 1994-08-16 |
| Date of Event | 1994-08-05 |
| Date Facility Aware | 1994-08-05 |
| Report Date | 1994-08-16 |
| Date Reported to Mfgr | 1994-08-12 |
| Date Added to Maude | 1995-09-06 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AESCULAP #FF562 |
| Generic Name | 2MM RONGEURE FORCEP |
| Product Code | EMH |
| Date Received | 1995-01-18 |
| Model Number | N/A |
| Catalog Number | FF562 |
| Lot Number | N/A |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 18 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 25672 |
| Manufacturer | AESCULAP INSTRUMENTS |
| Manufacturer Address | 1000 GATEWAY BOULEVAD SAN FRANCISCO CA 94080 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-01-18 |