MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-09-15 for EPICOR ULTRACINCH LP ABLATION DEVICE UC-LP-10 * manufactured by St. Jude Medical.
[16037395]
The epicor cinch was connected to the machine. During the self test, the screen displayed "4 damaged cells. " i disconnected the cinch and reconnected the cinch to machine. The machine performed another self test. Again the display read "4 damaged cells. " i turned the machine off, then repeated the process. After the damaged cells displayed the third time, we removed the cinch from the field and opened a new one. The new one worked. The damaged one was never used on the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1869375 |
| MDR Report Key | 1869375 |
| Date Received | 2010-09-15 |
| Date of Report | 2010-09-15 |
| Date of Event | 2010-08-28 |
| Report Date | 2010-09-15 |
| Date Reported to FDA | 2010-09-15 |
| Date Added to Maude | 2010-10-14 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 | EPICOR ULTRACINCH LP ABLATION DEVICE |
| Generic Name | SYSTEM, ABLATION |
| Product Code | NTB |
| Date Received | 2010-09-15 |
| Returned To Mfg | 2010-09-15 |
| Model Number | UC-LP-10 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | UNKNOWN |
| Device Availability | R |
| Device Age | 2 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL |
| Manufacturer Address | 240 SANTA ANA COURT SUNNYVALE CA 94085 US 94085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-09-15 |