MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-08-17 for SKYTRON * manufactured by Amatech Corp.
[2990025]
In response to (b)(6), skytron contacted our distributor in the area, (b)(4), who sent their territory manager to the facility. He could not make a determination as to the cause of the tri-clamp failure and will send the clamp to skytron for eval. When that eval has been completed, we will send the fda add'l info. The facility only uses this attachment for one surgeon and one procedure type. They have decided to utilize stirrups instead of the split leg with the tri-clamp at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825014-2012-00008 |
| MDR Report Key | 2715768 |
| Date Received | 2012-08-17 |
| Date Facility Aware | 2012-08-02 |
| Report Date | 2012-08-16 |
| Date Reported to FDA | 2012-08-16 |
| Date Reported to Mfgr | 2012-08-16 |
| Date Added to Maude | 2012-08-27 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKYTRON |
| Generic Name | TRI-CLAMP |
| Product Code | BWN |
| Date Received | 2012-08-17 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 5 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMATECH CORP |
| Manufacturer Address | * ACTON MA * US * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-17 |