MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE GIO

Model Number	TFH9100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Dislocation (2374); Neck Pain (2433)
Date of Event	01/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure's medical opinion is that the contribution of device use to the rib injury and neck pain cannot be ruled out.Chest injury was not reported as an expected event with optune gio device use in the (ef-11 or ef-14 trial in optune arm).There have been 3 reports of chest injury in the commercial program to date.All of them were unrelated to device use.Neck pain is an expected event with optune gio device use (ef-11 0% and 1% ef-14 optune arm).
Event or Problem Description
A 58-year-old female patient with newly diagnosed glioblastoma (gbm) started optune gio on (b)(6) 2024.On (b)(6) 2025, the patient reported to novocure that on (b)(6) 2025; while walking fast past a door, the array cords became entangled on a doorknob, causing her to be pulled backward.The patient subsequently experienced neck pain, described as a whiplash-like sensation.Following the incident, she sought chiropractic care, during which it was noted that two of her ribs had become displaced.Attempts to contact the prescribing physician for further details were made, but no response was received.

• Brand Name: OPTUNE GIO
• Common Device Name: OPTUNE GIO
• Manufacturer (Section D): NOVOCURE GMBH; neuhofstrasse 21; baar, 6340 ; SZ 6340
• Manufacturer (Section G): NOVOCURE GMBH; neuhofstrasse 21; baar, 6340 ; SZ 6340
• Manufacturer Contact: sharon perez ; 180 hanover st.; portsmouth, NH 03801 ; 2077527602
• MDR Report Key: 21408234
• Report Number: 3010457505-2025-00440
• Device Sequence Number: 8214889
• Product Code: NZK
• UDI-Device Identifier: 07290107982207
• UDI-Public: (01)07290107982207(11)190715
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: TFH9100
• Device Catalogue Number: TFH9100US
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACETAMINOPHEN; ACYCLOVIR; BETAMETHASONE DIPROPIONATE FOAM; CETIRIZINE; DEXAMETHASONE; FAMOTIDINE; IBUPROFEN; IPRATROPIUM; LORAZEPAM; MULTIVITAMIN; OLANZAPINE; ONDANSETRON; PREDNISONE; PREGABALIN; PROMETHAZINE-DEXTROMETHORPHAN; TEMOZOLOMIDE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female