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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MONTERIS MEDICAL CORPORATION FULLFIRE DIFFUSING TIP LASER PROBE; FULLFIRE¿ DIFFUSING TIP LASER PROBE
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MONTERIS MEDICAL CORPORATION FULLFIRE DIFFUSING TIP LASER PROBE; FULLFIRE¿ DIFFUSING TIP LASER PROBE Back to Search Results
Catalog Number DTP-101--01
Medical Device Problem Code Temperature Problem (3022)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/09/2016
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during an ablation procedure, there was unintended probe heating.There were no patient complications reported in relation to this event.If additional information is received, a follow up report will be submitted.
 
Additional Manufacturer Narrative
Device evaluation: review of the software logs were performed.A probe temperature was recorded in the hardware log files which showed evidence of possible unintended heating of the probe.
 
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Brand Name
FULLFIRE DIFFUSING TIP LASER PROBE
Common Device Name
FULLFIRE¿ DIFFUSING TIP LASER PROBE
Manufacturer (Section D)
MONTERIS MEDICAL CORPORATION
14755 27th ave n
suite c
plymouth MN 55447
MDR Report Key6887357
Report Number3009970070-2017-00141
Device Sequence Number10962807
Product Code GEX
UDI-Device Identifier00816589020533
UDI-Public00816589020533
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K081509
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,other
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 09/22/2017
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 Date08/03/2016
Device Catalogue NumberDTP-101--01
Device Lot NumberC7381-05
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 09/07/2017
Supplement Date Received by Manufacturer09/26/2017
Initial Report FDA Received Date09/22/2017
Supplement Report FDA Received Date10/03/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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