RUSCH GREENSPEC FIBEROPTIC HANDLE, MEDIUM 004411100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2012-12-19 for RUSCH GREENSPEC FIBEROPTIC HANDLE, MEDIUM 004411100 manufactured by Teleflex.

Event Text Entries

[3101368] Complaint is reported as: when two "c" size batteries are installed into the handle the battery retainer cap begins to heat. This occurred during post op inspection, after sterilization.
Patient Sequence No: 1, Text Type: D, B5


[10388443] Product has not yet received by manufacturer, therefore, investigation report is incomplete at this time. A follow-up report will be submitted when investigation is complete.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1044475-2012-00167
MDR Report Key2885823
Report Source06,07
Date Received2012-12-19
Date of Report2012-12-07
Date Mfgr Received2012-12-07
Date Added to Maude2013-03-22
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 ContactKATHARINE TARPLEY
Manufacturer StreetP.O. BOX 12600
Manufacturer CityRESEARCH TRIANGLE PARK NC 27709
Manufacturer CountryUS
Manufacturer Postal27709
Manufacturer Phone9194334854
Manufacturer G1TELEFLEX
Manufacturer Street2917 WECK DR.
Manufacturer CityRESEARCH TRIANGLE PARK NC 27709
Manufacturer CountryUS
Manufacturer Postal Code27709
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRUSCH GREENSPEC FIBEROPTIC HANDLE, MEDIUM
Generic NameGREENSPEC FIBEROPTIC HANDLE
Product CodeEQN
Date Received2012-12-19
Catalog Number004411100
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX
Manufacturer AddressRESEARCH TRIANGLE PARK NC US


Patients

Patient NumberTreatmentOutcomeDate
10 2012-12-19

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