MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-06-27 for SMART STAPES PISTON 70145923 manufactured by Gyrus Acmi, Inc..
[3631954]
It was reported that during a surgical procedure the smart stapes piston was implanted in the pts ear. The surgeon noticed the piston was falling backwards against the facial nerve when placed initially and decided to remove it. During the removal procedure, the piston separated and fell into the pts middle ear. Most of the foot plate was taken out. The surgeon stated that it was difficult to retrieve the piston as it was against the facial nerve and had to remove 2mm of the vestibule. The incident resulted in extended surgical time as well as leaving the pt with some hearing loss and experience of dizziness since the procedure. The intended procedure was completed. Additional treatment was required, the graft from the pt's hand was used to replaced the 2mm vestibule. A new piston was implanted in the pts ear.
Patient Sequence No: 1, Text Type: D, B5
[10971747]
An investigation was performed on the returned product. The investigation revealed that the product was not manufactured to specifications. A review of the dhr and previous complaint history has been done. Cyrus acmi will continue to monitor future reports.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1037007-2013-00010 |
| MDR Report Key | 3199452 |
| Report Source | 07 |
| Date Received | 2013-06-27 |
| Date of Report | 2013-05-30 |
| Date of Event | 2013-05-13 |
| Date Mfgr Received | 2013-05-30 |
| Date Added to Maude | 2013-07-02 |
| 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 | TERRENCE SULLIVAN |
| Manufacturer Street | 136 TURNPIKE ROAD |
| Manufacturer City | SOUTHBOROUGH MA 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 5088042739 |
| Manufacturer G1 | GYRUS ACMI, INC. |
| Manufacturer Street | 2925 APPLING RD. |
| Manufacturer City | BARTLETT TN 38133390 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38133 3901 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMART STAPES PISTON |
| Generic Name | SMART STAPES PISTON |
| Product Code | ETB |
| Date Received | 2013-06-27 |
| Returned To Mfg | 2013-06-14 |
| Model Number | 70145923 |
| Catalog Number | 70145923 |
| Lot Number | MH51432 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC. |
| Manufacturer Address | BARTLETT TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2013-06-27 |