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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MONTERIS MEDICAL NEUROBLATE OPTIC FULLFIRE® LASER PROBE
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MONTERIS MEDICAL NEUROBLATE OPTIC FULLFIRE® LASER PROBE Back to Search Results
Model Number 20893-000
Medical Device Problem Codes Fracture (1260); Insufficient Heating (1287)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/01/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device evaluation: probe was returned and cleaned, laser fiber break was confirmed as a kinked fiber at approximately 50mm from connector strain relief end.The black fiber jacket prevented laser light leakage through the side of the wall.
 
Event or Problem Description
It was reported that during an ablation procedure, upon plugging in the probe, it was noted that the indicator light was very dim.The surgeon did not want to use the probe.Another probe was used successfully.There were no patient complications reported in relation to this event.
 
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Brand Name
NEUROBLATE OPTIC FULLFIRE® LASER PROBE
Common Device Name
NEUROBLATE OPTIC FULLFIRE® LASER PROBE
Manufacturer (Section D)
MONTERIS MEDICAL
14755 27th ave n
suite c
plymouth MN 55447
MDR Report Key9226687
Report Number3009970070-2019-00086
Device Sequence Number2409255
Product Code GEX
UDI-Device Identifier00816589020953
UDI-Public00816589020953
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K182036
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date02/04/2021
Device Model Number20893-000
Device Catalogue NumberDTP-000-01
Device Lot Number279A9
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/07/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/01/2019
Initial Report FDA Received Date10/23/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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