MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-27 for CLASSIC SERIES? REUSABLE ACTIVE CORD FOR BOVIE?/VALLEYLAB CONNECTION C650-129A manufactured by Gyrus Acmi, Inc..
[90507026]
Patient Sequence No: 1, Text Type: N, H10
[90507027]
Bugbee cord and bovie 10138 due to bugbee cord catching fire while in surgeon's hand; extinguished with sterile water and bovie unplugged; surgeon's gown with visible hole noted; charge nurse and engineering notified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6984999 |
| MDR Report Key | 6984999 |
| Date Received | 2017-10-27 |
| Date of Report | 2017-10-04 |
| Date of Event | 2017-08-17 |
| Report Date | 2017-10-04 |
| Date Reported to FDA | 2017-10-04 |
| Date Reported to Mfgr | 2017-10-04 |
| Date Added to Maude | 2017-10-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLASSIC SERIES? REUSABLE ACTIVE CORD FOR BOVIE?/VALLEYLAB CONNECTION |
| Generic Name | ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL |
| Product Code | NLW |
| Date Received | 2017-10-27 |
| Model Number | C650-129A |
| Catalog Number | C650-129A |
| Lot Number | UNKNOWN |
| Operator | PHYSICIAN |
| Device Availability | Y |
| 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 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-27 |