MAUDE Adverse Event Report: MONTERIS MEDICAL CORPORATION NEUROBLATE PROBE DRIVER; POWERED LASER SURGICAL INSTRUMENT

Model Number NBD-01

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2015

Event Type  malfunction  

Manufacturer Narrative

On the day of the event, the patient had the probe inserted according to procedure.There was an approximate 60 minute delay between probe insertion and the procedure due to mr availability.Upon access to the mr, the probe and probe driver were connected to the system.There were no unusual events observed or reported.After reconnection the software position was offset from actual due to an unknown cause.This required resetting or replacing the driver per ifu.The surgeon reported that due to the complexity of the patient's lesion and the length of time between the probe placement and the availability of the mr, they decided to proceed with craniotomy rather than replacing the probe driver.Probe movement is controlled by the system's computer sending power to the advanced probe driver.The advanced probe driver has no capability to automatically move the probe independently.The neuroblate software displays an mri image of the probe and the actual depth of the probe as a measurement.Prior to treatment, the user aligns the mri image with the actual depth.If the image display and the probe depth are not within +/-1mm, the system will provide an onscreen prompt requesting confirmation that the user would like to move the probe to align with the mri image.This is a safety feature to ensure system stability prior to treatment proceeding.The probe driver was returned and testing could not recreate the reported situation.The probe driver demonstrated stable position feedback through multiple depths.A review of the case logs from the software confirmed that the software performed as expected.

Event Description

A user facility report was received from the hospital for this event.According to the information received, the advanced probe driver and probe were placed in the patient's head to the desired depth.After the planning scan was complete and before the treatment, it was noticed on the software that the probe had retracted 2.5 cm.The clinical specialist then went into the or to physically look at the probe driver and it was confirmed that the probe had moved.Instead of replacing the probe driver, the physician opted to perform a craniotomy.

• Brand Name: NEUROBLATE PROBE DRIVER
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): MONTERIS MEDICAL CORPORATION; 16305 36th avenue north; suite 200; plymouth MN 55446
• Manufacturer (Section G): MONTERIS MEDICAL CORPORATION; 16305 36th avenue north; suite 200; plymouth MN 55446
• Manufacturer Contact: jordon honeck ; 14755 27th ave n; suite c; plymouth, MN 55447 ; 7632534721
• MDR Report Key: 5646644
• MDR Text Key: 45199608
• Report Number: 3009970070-2015-00006
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131955
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: NBD-01
• Device Catalogue Number: NBD-01
• Device Lot Number: 20369-C3573-09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 75