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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MONTERIS MEDICAL NEUROBLATE OPTIC SIDEFIRE® LASER PROBE
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MONTERIS MEDICAL NEUROBLATE OPTIC SIDEFIRE® LASER PROBE Back to Search Results
Model Number 20891-000
Medical Device Problem Codes Fracture (1260); Insufficient Heating (1287)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/06/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device evaluation: the device was returned and cleaned.A laser fiber break was confirmed via pilot light leakage through the umbilical approximately 30mm above the tube holder.
 
Event or Problem Description
It was reported that during an ablation procedure, the first laser that was opened had a break in the fiber.There were no patient complications reported in relation to this event.
 
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Brand Name
NEUROBLATE OPTIC SIDEFIRE® LASER PROBE
Common Device Name
NEUROBLATE OPTIC SIDEFIRE® LASER PROBE
Manufacturer (Section D)
MONTERIS MEDICAL
14755 27th ave n
suite c
plymouth MN 55447
MDR Report Key8946925
Report Number3009970070-2019-00067
Device Sequence Number16796766
Product Code GEX
UDI-Device Identifier00816589020885
UDI-Public00816589020885
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) 08/29/2019
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 Date09/11/2020
Device Model Number20891-000
Device Catalogue NumberNBP-000-01
Device Lot Number41859
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/06/2019
Initial Report FDA Received Date08/29/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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