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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 20891-1
Medical Device Problem Codes Fracture (1260); Insufficient Heating (1287)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/08/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device evaluation: probe was returned and cleaned, laser fiber break was confirmed via pilot light leakage through fiber at approximately 25mm from the connector end.
 
Event or Problem Description
It was reported that during an ablation procedure, while testing the laser output prior to insertion, the laser light was visibly emitting within the white cord that leads to the laser connector.It was noted it the damage may have occurred while being removed from the packaging.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 Key9226688
Report Number3009970070-2019-00087
Device Sequence Number1573328
Product Code GEX
UDI-Device Identifier00816589020892
UDI-Public00816589020892
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 Date09/26/2020
Device Model Number20891-1
Device Catalogue NumberNBP-101-01
Device Lot Number41865
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/14/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/07/2019
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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