MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-19 for BOSS EAR CUP FORCEPS 90-2181 * manufactured by Boss Instruments, Ltd..
[18896428]
During an operative procedure, a micropituitary being used by doctor broke. The metal piece that broke off was retrieved. The instrument was removed from the sterile field and given to materials coord. An x-ray was taken and read as negative for metal. Doctor aware of x-ray results. No harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4722176 |
| MDR Report Key | 4722176 |
| Date Received | 2015-03-19 |
| Date of Report | 2015-03-19 |
| Date of Event | 2015-01-02 |
| Report Date | 2015-03-19 |
| Date Reported to FDA | 2015-03-19 |
| Date Reported to Mfgr | 2015-04-23 |
| Date Added to Maude | 2015-04-23 |
| 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 |
| 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 | BOSS EAR CUP FORCEPS |
| Generic Name | FORCEPS, ENT |
| Product Code | KAE |
| Date Received | 2015-03-19 |
| Model Number | 90-2181 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSS INSTRUMENTS, LTD. |
| Manufacturer Address | 104 SOMMERFIELD DRIVE GORDONSVILLE VA 22942 US 22942 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-19 |