MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2017-09-02 for VALLEYLAB E6008 manufactured by Covidien Mfg Dc Boulder.
[84707695]
One used monopolar pedal was received, and examination of the sample confirmed an issue with continued activation. Evaluation found the push-pedal sticks when pushed down, and continues to activate when a foot is lifted from the pedal. Further investigation found the issue to be due to a saline liquid spill on the pedal. This was indicated by residue along the axis of the bar and an excess amount of dirt around the same axis point. It is possible that this issue can cause an electrical arc on the tip, which would result in a flame if flammable material is present. 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
[84707696]
The customer reported that during a procedure where this footswitch was used, an issue resulted in second degree burns to the thighs of the patient. When the surgeon was performing hemostasis, the blanket under the patient started to burn. The burns were treated within the hospital.
Patient Sequence No: 1, Text Type: D, B5
[131401139]
This issue was originally reported for the involved e6008 foot-pedal under manufacturer report number: 1717344-2017-05639. Fda was notified of the issue on (b)(6) 2017, within the 30-day time frame. All further reports regarding this issue for the e6008 foot-pedal will be submitted under manufacturer report number 1717344-2017-05841. An additional device involved in this issue has been reported under manufacturer report number 1717344-2017-05612. Revised to the date that the additional information was received for the last report, submitted on september 2, 2017. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2017-05841 |
| MDR Report Key | 6840659 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2017-09-02 |
| Date of Report | 2017-06-28 |
| Date of Event | 2017-06-27 |
| Date Mfgr Received | 2017-08-03 |
| Date Added to Maude | 2017-09-02 |
| 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 | 2017-09-02 |
| Returned To Mfg | 2017-06-29 |
| Model Number | E6008 |
| Catalog Number | E6008 |
| Lot Number | 568137 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-09-02 |