MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-01-02 for GRYUS APPLEBAUM INDUDO-STAPEDIAL JOINT 2.0MM 140956 manufactured by Gyrus Acmi, Inc..
[5302344]
Olympus was informed that during a therapeutic stapedectomy procedure, the physician was placing the applebaum prosthesis into place when it broke into 2 pieces. Reportedly, one piece was lost in the middle ear and the other fragment was successfully retrieved. The intended procedure was completed with a big easy stapes prosthesis. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[12645910]
The device referenced in this report has not yet been returned to olympus for evaluation. The exact cause of the reported event could not be conclusively determined. If additional information becomes available at a later time, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951238-2014-00637 |
| MDR Report Key | 4399248 |
| Report Source | 05,06 |
| Date Received | 2015-01-02 |
| Date of Report | 2014-12-04 |
| Date of Event | 2014-11-17 |
| Date Mfgr Received | 2014-12-04 |
| Date Added to Maude | 2015-01-21 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | NOEMI SCHAMBACH |
| Manufacturer Street | 2400 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE CA 951311700 |
| Manufacturer Country | US |
| Manufacturer Postal | 951311700 |
| Manufacturer Phone | 4089355002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GRYUS APPLEBAUM INDUDO-STAPEDIAL JOINT 2.0MM |
| Generic Name | APPLEBAUM PROTHESIS |
| Product Code | ETB |
| Date Received | 2015-01-02 |
| Model Number | 140956 |
| Catalog Number | 140956 |
| Lot Number | UNK |
| ID Number | NA |
| 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 01772210 01772 2104 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-02 |