TROPHON EPR * E8350NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-01 for TROPHON EPR * E8350NA manufactured by Nanosonics Inc..

Event Text Entries

[20700868] The heat from the trophon is loosening the epoxy that holds the vaginal probe together. The vaginal probes are falling apart. We have had 6 vaginal probes to fall apart since using the trophon. Therefore, we have had to purchase new probes. The trophon utilizes a hydrogen based chemical sterilization solution. We believe this may be contributing to the loosening of the epoxy of the vaginal probes and thus causing them to break. Our facility is in the process of returning all 12 trophons back to the manufacturer.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3853109
MDR Report Key3853109
Date Received2014-05-01
Date of Report2014-05-01
Date of Event2014-04-24
Report Date2014-05-01
Date Reported to FDA2014-05-01
Date Reported to Mfgr2014-06-06
Date Added to Maude2014-06-06
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameTROPHON EPR
Generic NameHIGH LEVEL DISINFECTION REPROCESSING INSTRUMENT FOR ULTRASONIC TRANSDUCERS
Product CodeOUJ
Date Received2014-05-01
Model Number*
Catalog NumberE8350NA
Lot Number*
ID Number*
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerNANOSONICS INC.
Manufacturer Address1209 KINGSLEY CT LOWER GWYNEDD PA 19002 US 19002


Patients

Patient NumberTreatmentOutcomeDate
10 2014-05-01

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