STO27040G

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2012-05-24 for STO27040G manufactured by Sterilmed, Inc..

Event Text Entries

[2661192] It was reported that an electrode broke during a procedure.
Patient Sequence No: 1, Text Type: D, B5


[9977661] Final investigation showed that the cutting loop of the device was broken. The piece that broke off was returned with the device. It was not possible to determine what caused the cutting loop to break during use.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2134070-2012-00095
MDR Report Key2591228
Report Source01,08
Date Received2012-05-24
Date of Report2011-10-14
Date Mfgr Received2011-10-14
Device Manufacturer Date2011-06-01
Date Added to Maude2012-06-05
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 FDA0
Event Location0
Manufacturer ContactTRICIA SCHRATER
Manufacturer Street11400 73RD AVE. NORTH
Manufacturer CityMAPLE GROVE MN 55369
Manufacturer CountryUS
Manufacturer Postal55369
Manufacturer Phone7634883211
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNA
Generic NameENDOSCOPIC ELECTRODE (NLW)
Product CodeNLW
Date Received2012-05-24
Returned To Mfg2011-10-19
Model NumberSTO27040G
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTERILMED, INC.
Manufacturer AddressMAPLE GROVE MN US


Patients

Patient NumberTreatmentOutcomeDate
10 2012-05-24

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