VALLEYLAB E6008

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number1717344-2017-05639
MDR Report Key6750592
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2017-07-28
Date of Report2017-06-29
Date Mfgr Received2017-06-29
Date Added to Maude2017-07-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSHARON MURPHY
Manufacturer Street5920 LONGBOW DRIVE
Manufacturer CityBOULDER CO 80301
Manufacturer CountryUS
Manufacturer Postal80301
Manufacturer Phone2034925267
Manufacturer G1COVIDIEN MFG DC BOULDER
Manufacturer Street5920 LONGBOW DR
Manufacturer CityBOULDER CO 803013299
Manufacturer CountryUS
Manufacturer Postal Code803013299
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVALLEYLAB
Generic NameUNIT, ELECTROSURGICAL ANDCOAGULATION, WITH ACCESSORIES
Product CodeBWA
Date Received2017-07-28
Model NumberE6008
Catalog NumberE6008
Lot Number568137
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN MFG DC BOULDER
Manufacturer Address5920 LONGBOW DR BOULDER CO 803013299 US 803013299


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-07-28

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