MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2014-02-28 for PISTON W/ ARMSTRONG PLATINUM RIBBON LOOP 140764 manufactured by Gyrus Acmi Inc.
[18304540]
The user facility reported that during a stapes reconstruction procedure, the plasti-pore section of the implant separated from the ribbon loop. The plasti-pore section was not able to be retrieved and was left inside the pt. A second implant was then implanted. No pt injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[18435996]
The device ref in this report has not been returned to olympus for evaluation. If additional information or if the device is received at a later time this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951238-2014-00074 |
| MDR Report Key | 3697684 |
| Report Source | 01,06 |
| Date Received | 2014-02-28 |
| Date of Report | 2014-02-05 |
| Date of Event | 2014-02-05 |
| Date Mfgr Received | 2014-02-05 |
| Device Manufacturer Date | 2010-08-02 |
| Date Added to Maude | 2014-03-26 |
| 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 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355002 |
| Manufacturer G1 | GYRUS ACMI INC |
| Manufacturer Street | 136 TURNPIKE RD |
| Manufacturer City | SOUTHBOROUGH MA 01772210 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01772 2104 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PISTON W/ ARMSTRONG PLATINUM RIBBON LOOP |
| Generic Name | PISTON |
| Product Code | ETB |
| Date Received | 2014-02-28 |
| Model Number | 140764 |
| Catalog Number | 140764 |
| Lot Number | MH183544 |
| 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 RD SOUTHBOROUGH MA 01772210 US 01772 2104 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-02-28 |