MONTERIS MEDICAL NBP-001-01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-30 for MONTERIS MEDICAL NBP-001-01 manufactured by Monteris Medical.

Event Text Entries

[53600756] During neuroblate procedure, tip of probe was detached from base.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5064408
MDR Report Key5913323
Date Received2016-08-30
Date of Report2016-07-26
Date of Event2016-07-25
Date Added to Maude2016-08-30
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRADIOLOGIC TECHNOLOGIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameMONTERIS MEDICAL
Generic NameSIDEFIRE DIRECTIONAL LASER PROBE
Product CodeHQB
Date Received2016-08-30
Model NumberNBP-001-01
Device Expiration Date2017-11-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMONTERIS MEDICAL
Manufacturer Address16305 360 AVENUE STE 200 PLYMOUTH MN 55466 US 55466


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2016-08-30

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