MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-04-19 for SCHUK FLPL-SS WIRE PIST 140127 manufactured by Osta.
[43013297]
At the time of this report, the device has not yet been returned for evaluation, as a result a determination cannot be made at this time. If further information becomes available, gyrus acmi will continue the investigation and update the agency accordingly.
Patient Sequence No: 1, Text Type: N, H10
[43013298]
Operator put slight traction on the stainless steel wire in order to remove the piston. The wire came loose from the piston. Health hazard: extreme vertigo and some uncontrolled eye movement (nystagmus). No reduction in hearing levels postoperatively.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037007-2016-00002 |
| MDR Report Key | 5586869 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-04-19 |
| Date of Report | 2016-04-19 |
| Date of Event | 2016-01-21 |
| Date Mfgr Received | 2016-03-21 |
| Date Added to Maude | 2016-04-19 |
| 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 | MR TERRENCE SULLIVAN |
| Manufacturer Street | 136 TURNPIKE ROAD |
| Manufacturer City | SOUTHBOROUGH MA 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 508804-273 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCHUK FLPL-SS WIRE PIST |
| Generic Name | WIRE PISTON |
| Product Code | ETA |
| Date Received | 2016-04-19 |
| Model Number | 140127 |
| Lot Number | MH882682 |
| ID Number | UDI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSTA |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2016-04-19 |