MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2017-07-13 for ECLIPSE PISTON 468-425 manufactured by Grace Medical, Inc..
[80008214]
The stapes prosthesis was evaluated along with 6 other stapes prostheses from the same q. C. Lot number. There was evidence that the returned prosthesis had been in a surgical procedure but not trimmed or altered. The nitinol crook was activated with a heat source according to the ifu. It was found to meet all dimensional and functional design specifications. The remaining 6 stapes prostheses were also tested and met all dimensional and functional design specifications.
Patient Sequence No: 1, Text Type: N, H10
[80008215]
It was reported that this product was removed for a revision surgery, as the loop of the stapes prosthesis was found to be in the opened position.
Patient Sequence No: 1, Text Type: D, B5
[110081386]
Additional information was received from the physician regarding the date of the event and the date of explantation. The physician reported that the patient had otosclerosis with conductive hearing loss. The physician also reported that there was no injury to the patient.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000022662-2017-00001 |
| MDR Report Key | 6711913 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2017-07-13 |
| Date of Report | 2017-07-13 |
| Date of Event | 2015-11-20 |
| Date Mfgr Received | 2017-06-16 |
| Device Manufacturer Date | 2015-08-14 |
| Date Added to Maude | 2017-07-13 |
| 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. CARLYN REYNOLDS |
| Manufacturer Street | 8500 WOLF LAKE DRIVE SUITE 110 |
| Manufacturer City | MEMPHIS TN 381334104 |
| Manufacturer Country | US |
| Manufacturer Postal | 381334104 |
| Manufacturer Phone | 9013807000 |
| Manufacturer G1 | GRACE MEDICAL, INC. |
| Manufacturer Street | 8500 WOLF LAKE DRIVE SUITE 110 |
| Manufacturer City | MEMPHIS TN 381334104 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 381334104 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ECLIPSE PISTON |
| Generic Name | PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT |
| Product Code | ETB |
| Date Received | 2017-07-13 |
| Returned To Mfg | 2017-06-21 |
| Catalog Number | 468-425 |
| Lot Number | 39182 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GRACE MEDICAL, INC. |
| Manufacturer Address | 8500 WOLF LAKE DRIVE SUITE 110 MEMPHIS TN 381334104 US 381334104 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-07-13 |