MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-30 for FORCE FX FORCEFX manufactured by Covidien Lp.
[35173877]
(b)(4). Date of initial report : 12/29/2015. The return of the unit has been requested. To date it has not been received for evaluation. Additional questions in regard to the incident have also been asked. If the sample is received or if additional information pertinent to the incident is obtained a follow-up report will be submitted. A review of the device history record for this unit could not be conducted because a valid serial number was not provided.
Patient Sequence No: 1, Text Type: N, H10
[35173879]
The customer reported that a patient was burned during a craniotomy case while a force fx was being used. Additional questions regarding this incident have been asked of the site, but to date, no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1717344-2015-00939 |
| MDR Report Key | 5335059 |
| Date Received | 2015-12-30 |
| Date of Report | 2015-12-04 |
| Date Mfgr Received | 2015-12-04 |
| Date Added to Maude | 2015-12-30 |
| 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 |
| Manufacturer G1 | BOULDER |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FORCE FX |
| Generic Name | ELECTROSURGICAL GENERATOR |
| Product Code | BWA |
| Date Received | 2015-12-30 |
| Catalog Number | FORCEFX |
| 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 CO 80301 US 80301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-30 |