MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-05 for RAPIDVAC SMOKE EVACUATOR SE3690 manufactured by Covidien Lp.
[61721444]
(b)(4). To date, the incident sample has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[61721445]
The customer reported that during a piep flap procedure there were 2 rapidvac smoke evacuators, 3 smoke pencils, 2 forcetriads, 3 e7507 rem grounding pads and one plasma blade/plasma blade generator in use. When the surgeon went to activate the plasma blade the rapidvac activated instead. The surgeon also noted that the smoke pencil was activated while lying on the patient despite only activating the plasma blade. This caused a small burn on the right side of the patient under her breast. The burn was minor in nature and treated with ointment and dressing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1717344-2016-01126 |
| MDR Report Key | 6145823 |
| Date Received | 2016-12-05 |
| Date of Report | 2016-11-11 |
| Date of Event | 2016-11-11 |
| Date Mfgr Received | 2016-11-11 |
| Date Added to Maude | 2016-12-05 |
| 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 | SHARON MURPHY |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 2034925267 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RAPIDVAC SMOKE EVACUATOR |
| Generic Name | SMOKE EVACUATOR |
| Product Code | FYD |
| Date Received | 2016-12-05 |
| Model Number | SE3690 |
| Catalog Number | SE3690 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP |
| Manufacturer Address | 5920 LONGBOW DRIVE BOULDER BOULDER CO 80301 US 80301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-05 |