MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-07-28 for VALLEYLAB E6008 manufactured by Covidien Mfg Dc Boulder.
[81285880]
The incident devices have been received and are under evaluation. When the device evaluations are complete a follow-up report will be submitted. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[81285881]
According to the reporter, during inguinal hernia procedure, the e6008 footpedal continued to be powered on even when it was no longer activated. This happened when hemostasis started. The reporter also indicated that chlorhexidine and a non-medtronic return electrode were utilized under the patient when the patient received a second degree burn at the return electrode pad site.
Patient Sequence No: 1, Text Type: D, B5
[131397415]
This incident was inadvertently duplicated in regulatory report #: 1717344-2017-05639. Please see regulatory report #: 1717344-2017-05612 (medtronic tracking #: (b)(4), task id: (b)(4)) for the original report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2017-05639 |
| MDR Report Key | 6750592 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-07-28 |
| Date of Report | 2017-06-29 |
| Date Mfgr Received | 2017-06-29 |
| Date Added to Maude | 2017-07-28 |
| 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 | COVIDIEN MFG DC BOULDER |
| Manufacturer Street | 5920 LONGBOW DR |
| Manufacturer City | BOULDER CO 803013299 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 803013299 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VALLEYLAB |
| Generic Name | UNIT, ELECTROSURGICAL ANDCOAGULATION, WITH ACCESSORIES |
| Product Code | BWA |
| Date Received | 2017-07-28 |
| Model Number | E6008 |
| Catalog Number | E6008 |
| Lot Number | 568137 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN MFG DC BOULDER |
| Manufacturer Address | 5920 LONGBOW DR BOULDER CO 803013299 US 803013299 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-28 |