SURGISTAT VLSURGGEN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-31 for SURGISTAT VLSURGGEN manufactured by Covidien Mfg Dc Boulder.

Event Text Entries

[185708388] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185708389] According to the reporter, prior to use, the unit's output was too high. The veterinarian was burnt.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1717344-2020-00357
MDR Report Key9902212
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-12
Date Mfgr Received2020-03-12
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactLISA HERNANDEZ
Manufacturer Street5920 LONGBOW DRIVE
Manufacturer CityBOULDER CO 80301
Manufacturer CountryUS
Manufacturer Postal80301
Manufacturer Phone2034925563
Manufacturer G1COVIDIEN MFG DC BOULDER
Manufacturer Street5115 ULMERTON RD
Manufacturer CityCLEARWATER FL 33760
Manufacturer CountryUS
Manufacturer Postal Code33760
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSURGISTAT
Generic NameELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Product CodeGEI
Date Received2020-03-31
Returned To Mfg2020-03-30
Model NumberVLSURGGEN
Catalog NumberVLSURGGEN
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN MFG DC BOULDER
Manufacturer Address5115 ULMERTON RD CLEARWATER FL 33760 US 33760


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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