MAUDE Adverse Event Report: MONTERIS MEDICAL NEUROBLATE OPTIC FULLFIRE LASER PROBE; NEUROBLATE OPTIC FULLFIRE® LASER PROBE

Model Number	20895-1
Medical Device Problem Codes	Material Twisted/Bent (2981); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the probe was visually inspected.Blood was observed on the probe shaft.The probe was then cleaned with wipes, and blood was still observed between the inner and remainder of the outer shaft, within the probe shaft holder, and on the undersides of the depth stop.The outer probe shaft was torn at 60mm from inner shaft end; the inner shaft appeared intact with no holes observed.No adhesive was present on uncovered inner shaft.The adhesive was present between the inner shaft and remainder of the outer shaft.The outer and inner probe shafts were permanently bent 95mm from the inner shaft end (explained as due to handling prior to shipping back to monteris for analysis).The fiber tip was missing (explained as due ot handling prior to shipping back to monteris for analysis).From the returned product investigation, a kink in the probe shaft was confirmed.The kink location aligned with the base of the mini-bolt, and was suspected to have occurred during insertion of patient into the bore.The report that the probe was noticeably loose supports the theory that the mini-bolt with probe inside bent over during insertion or up until movement deeper, kinking the probe and stressing the outer tubing, and increasing the diameter of the probe such that it interfered with the id of the mini-bolt.Subsequent probe retraction attempts were difficult, and a purely manual rpd retraction followed by a sudden jump in linear position suggest that the manual retraction tore the outer probe sheath.The six cooling starts attempted after this event coincide with extraneous tdt lines, blue pixels, and areas of rapid low magnitude region growth.
Event or Problem Description
It was reported that during an ablation procedure, in the first ablation sequence, initial probe movement to the target linear position timed out, but eventually the probe reached the target linear position.Initial two laser ablation sequences were completed.On the third ablation sequence, the probe was commanded to move but did not reach its linear target.Manual rotation of the robotic probe driver (rpd) was performed to retract the probe to the target position, culminating in a purely manual rpd move with an unexpected rapid position change.Ablation could not be continued as the image was noisy, causing idl errors and putting the system into safe mode.During probe removal, the outer shaft and lens separated from the rest of the probe and remained in the patient.No probe resistance was noted when the probe was removed from the patient.The mini-bolt was noticeably loose on the skull.Ct scans of the patient taken post-op shows artifacts which appear to be the remaining outer shaft segment with the lens attached.The next day, probe was removed without reported incident.There were no patient complications reported in relation to this event.

• Brand Name: NEUROBLATE OPTIC FULLFIRE LASER PROBE
• Common Device Name: NEUROBLATE OPTIC FULLFIRE® LASER PROBE
• Manufacturer (Section D): MONTERIS MEDICAL; 14755 27th ave n; suite c; plymouth, mn
• MDR Report Key: 10408009
• Report Number: 3009970070-2020-00070
• Device Sequence Number: 3257023
• Product Code: GEX
• UDI-Device Identifier: 00816589021035
• UDI-Public: 00816589021035
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/14/2020

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 Date: 04/03/2021
• Device Model Number: 20895-1
• Device Catalogue Number: FFS122-01
• Device Lot Number: D1779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 08/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1