MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-06-06 for EAR CUP FORCEP 3.0MM, STRAIGHT JAWS * 58-4630 manufactured by Specialty Surgical Instrumentation.
[19106488]
Surgeon using ear cup forceps 58-4630 3. 0mm straight jaws during procedure. The tip of the ear cup forcep broke. Pieces gathered from surgical site. Procedure completed without further incidence. No untoward effects. Patient to recovery in stable condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2626234 |
| MDR Report Key | 2626234 |
| Date Received | 2012-06-06 |
| Date of Report | 2012-06-06 |
| Date of Event | 2012-05-25 |
| Report Date | 2012-06-06 |
| Date Reported to FDA | 2012-06-06 |
| Date Added to Maude | 2012-06-22 |
| 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 | 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 | EAR CUP FORCEP 3.0MM, STRAIGHT JAWS |
| Generic Name | FORCEPS, ENT |
| Product Code | KAE |
| Date Received | 2012-06-06 |
| Model Number | * |
| Catalog Number | 58-4630 |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPECIALTY SURGICAL INSTRUMENTATION |
| Manufacturer Address | 3034 OWEN DRIVE ANTIOCH TN 37013 US 37013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-06-06 |