WET-FIELD HEMOSTATIC ERASER * 221265

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-03-22 for WET-FIELD HEMOSTATIC ERASER * 221265 manufactured by Medtronic Ophthalmics.

Event Text Entries

[1892863] Physician noticed that the bipolar probe was not coagulating blood vessels and then the handpiece heated up.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2036937
MDR Report Key2036937
Date Received2011-03-22
Date of Report2011-03-22
Date of Event2011-01-13
Report Date2011-03-22
Date Reported to FDA2011-03-22
Date Added to Maude2011-04-01
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameWET-FIELD HEMOSTATIC ERASER
Generic NameBIPOLAR PROBE
Product CodeHQR
Date Received2011-03-22
Model Number*
Catalog Number221265
Lot Number*
ID Number*
OperatorPHYSICIAN
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC OPHTHALMICS
Manufacturer Address7611 NORTHLAND DRIVE MINNEAPOLIS MN 55432 US 55432


Patients

Patient NumberTreatmentOutcomeDate
10 2011-03-22

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.