MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER VALLEYLAB; UNIT, ELECTROSURGICAL ANDCOAGULATION, WITH ACCESSORIES

Model Number E6008

Device Problem Device Remains Activated (1525)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 06/27/2017

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: VALLEYLAB
• Type of Device: UNIT, ELECTROSURGICAL ANDCOAGULATION, WITH ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: sharon murphy ; 5920 longbow drive; boulder, CO 80301 ; 2034925267
• MDR Report Key: 6840659
• MDR Text Key: 84707695
• Report Number: 1717344-2017-05841
• Device Sequence Number: 1
• Product Code: BWA
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E6008
• Device Catalogue Number: E6008
• Device Lot Number: 568137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1