NEUROBLATE® SYSTEM

MDR report key: 6066284 · Received October 31, 2016

Report

Report Number: 3009970070-2016-00024
Event Type: Malfunction
Date Received: October 31, 2016
Date of Event: October 4, 2016
Report Date: October 4, 2016
Manufacturer: MONTERIS MEDICAL CORPORATION
Product Code: GEX
PMA / PMN Number: K162762
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

EVALUATION: REVIEW OF THE SOFTWARE LOGS CONFIRMED THE MALFUNCTION OF AUTO-REGISTER NOT WORKING PROPERLY.

Description of Event or Problem · 1

FOLLOWING TRAJECTORY SETTING UP IN THE OR, MRI WITH CONTRAST CONFIRMED THE TRAJECTORY WAS NOT ALIGNED PROPERLY. THE PATIENT RETURNED TO THE OR TO REPOSITION THE BOLT AND REALIGN THE TRAJECTORY. THE PATIENT RETURNED TO THE MRI, WAS RE-REGISTERED AND A NEW TREATMENT PLAN WAS INITIATED. THE CURRENT 3D SCAN WAS SENT TO WORKSTATION AND THE PREVIOUS 3D WITH GAD WAS IMPORTED. AUTO-REGISTER DID NOT WORK AND IMAGES WOULD NOT FUSE CORRECTLY. A SECOND DOSE OF GAD WAS REQUIRED TO RE-SCAN AND CONTINUE WITH TREATMENT. ALTHOUGH NO DEATH OR INJURY HAVE BEEN ASSOCIATED WITH THIS CASE, THIS EVENT IS BEING REPORTED BECAUSE THE PATIENT REQUIRED ADDITIONAL MEDICATIONS TO RE-SCAN/IMAGE TO PROCEED WITH TREATMENT. THERE WAS CONCERN REGARDING THE ADDITIONAL DOSE OF GAD DUE TO THE PATIENT'S IMPAIRED RENAL FUNCTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
718180	NEUROBLATE® SYSTEM	NEUROBLATE SYSTEM	GEX	MONTERIS MEDICAL CORPORATION	20368

Patients

Seq	Age	Sex	Outcome	Treatment
1