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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MONTERIS MEDICAL MONTERIS NEUROBLATE SYSTEM INTERSTITIAL THERMAL LASER

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MONTERIS MEDICAL MONTERIS NEUROBLATE SYSTEM INTERSTITIAL THERMAL LASER Back to Search Results
Model Number DTP-101-01
Device Problems Entrapment of Device; Material Fragmentation; Device Dislodged or Dislocated
Event Date 03/05/2015
Event Type  Injury  
Event Description

This was a (b)(6) patient with a history of seizures and a astrocytoma. The patient was having laser interstitial thermal therapy procedure on her astrocytoma. She was taken to the siemens realtime mir for the procedure which was performed without complication. The complication occurred when the laser probe was being removed. During the completion of the ablation procedure, the laser tip was withdrawn from the cranium bolt and it was noticed that the laser crystal, or stylus, was not attached to the wand. It was necessary for the patient to be taken to the operating room and the burr hole enlarged to remove the stylus. The patient went home the following day and post op follow up was very positive. There were no complications with the second operating room visit to retrieve the stylus.

 
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Brand NameMONTERIS NEUROBLATE SYSTEM
Type of DeviceINTERSTITIAL THERMAL LASER
Manufacturer (Section D)
MONTERIS MEDICAL
plymouth MN
MDR Report Key4649049
Report Number4649049
Device Sequence Number1
Product CodeLLZ
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 03/17/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/27/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2016
Device MODEL NumberDTP-101-01
Device LOT Number20414-1-C4663-16
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/17/2015
Distributor Facility Aware Date03/05/2015
Event Location Hospital
Date Report TO Manufacturer03/17/2015
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 03/27/2015 Patient Sequence Number: 1
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