MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2005-05-13 for BIRTCHER * 136064 manufactured by Conmed Electrosurgery.
[15687864]
The hospital states that the device activated without pressing the footswitch.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1720159-2005-00011 |
| MDR Report Key | 603747 |
| Report Source | 00 |
| Date Received | 2005-05-13 |
| Date of Report | 2005-05-12 |
| Date of Event | 2005-04-06 |
| Date Mfgr Received | 2005-04-06 |
| Date Added to Maude | 2005-05-19 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | REGINA JOZWIJK |
| Manufacturer Street | 14603 EAST FREMONT AVE |
| Manufacturer City | CENTENNIAL CO 80112 |
| Manufacturer Country | US |
| Manufacturer Postal | 80112 |
| Manufacturer Phone | 3032698237 |
| Manufacturer G1 | * |
| Manufacturer Street | 7211 SOUTH EAGLE ST |
| Manufacturer City | CENTENNIAL CO 80112 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80112 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIRTCHER |
| Generic Name | ELECTROSURGICAL GENERATOR WITH ARGON GAS |
| Product Code | FAR |
| Date Received | 2005-05-13 |
| Model Number | * |
| Catalog Number | 136064 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 593590 |
| Manufacturer | CONMED ELECTROSURGERY |
| Manufacturer Address | * CENTENNIAL CO * US |
| Baseline Brand Name | BIRCHER 6400 ABC |
| Baseline Generic Name | ELECTROSURGICAL GENERATOR |
| Baseline Model No | 136064 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-05-13 |