MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2019-01-10 for SMART STAPES PISTON .6 X 4.50 MM 70145928 manufactured by Gyrus Acmi, Inc.
[132645779]
The device was not returned to olympus for evaluation. The cause of the reported event cannot be determined at this time. However, the instruction for use warns users in the "precautions": care should be taken not to damage the bony structures, surrounding mucosa, chorda tympani, facial nerve, or any external tissue when applying heat to the wire loops. Olympus will continue to investigate this complaint to obtain more detailed information regarding the reported complaint. If additional information becomes available, this report will be updated and supplemented accordingly.
Patient Sequence No: 1, Text Type: N, H10
[132645780]
Olympus was informed that during an ear implant procedure, the piston was heated several times due to not crimping and resulted in the patient? S chorda tympani being burnt. It is unknown if the patient was treated or if the intended procedure was completed.
Patient Sequence No: 1, Text Type: D, B5
[134242960]
Olympus received additional information that states the device was held 0. 5mm to 1mm from the patient? S ear during activation. There was no bipolar cautery required for this procedure. The doctor reported that the patient has recovered well.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951238-2019-00352 |
| MDR Report Key | 8234422 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2019-01-10 |
| Date of Report | 2019-08-01 |
| Date of Event | 2018-12-13 |
| Date Mfgr Received | 2019-07-10 |
| Date Added to Maude | 2019-01-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMART STAPES PISTON .6 X 4.50 MM |
| Generic Name | SMART STAPES PISTON |
| Product Code | ETB |
| Date Received | 2019-01-10 |
| Model Number | 70145928 |
| Lot Number | MH594774 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-10 |