MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-11-10 for KERRISON RONGEUR N/A FF683 manufactured by Aesculap, Ag.
[7475]
During crainal surgery, the surgeon put "pressure" on the rongeur, causing it to pludge into the dura. The patient helth was not compromised and did not suffer any complications. The instrument was sent to manufacturer for evaluation. Investigation showed that there was no evidence of lubrication in the joints which resulted in fretting corrosion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-1993-00080 |
| MDR Report Key | 10320 |
| Date Received | 1993-11-10 |
| Date of Report | 1993-10-01 |
| Date of Event | 1993-09-17 |
| Date Facility Aware | 1993-09-20 |
| Report Date | 1993-10-01 |
| Date Added to Maude | 1993-12-01 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| 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 | KERRISON RONGEUR |
| Generic Name | RONGEUR |
| Product Code | EMH |
| Date Received | 1993-11-10 |
| Returned To Mfg | 1993-09-20 |
| Model Number | N/A |
| Catalog Number | FF683 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 10320 |
| Manufacturer | AESCULAP, AG |
| Manufacturer Address | 125 MOEHRINGER STRASSE D-7200 TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-11-10 |