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 Code	Laceration(s) (1946)
Date of Event	09/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A 77-year-old female with newly diagnosed glioblastoma (gbm) started optune gio therapy on (b)(6) 2021.On (b)(6) 2025, the patient's spouse informed novocure that the patient experienced a fall on (b)(6) 2025.The spouse reported that he was unsure of the exact circumstances, but the patient was walking down the hallway when she collapsed.The patient was reportedly coherent and responsive.Subsequently, the patient was taken to the hospital and admitted to the intensive care unit, where a (ct) computed tomography scan revealed two intracranial hemorrhages and a suspected seizure.In addition, the incident resulted in a minor laceration to the occipital region of the scalp, which required closure with four staples.The patient was on anti-seizure medication and adjustments to her regimen were made.At the time of the fall, the patient was wearing the optune gio device.An image provided shows the occipital scalp area with four staples in place with the transducer arrays placed to avoid the affected area.No signs of active bleeding, drainage, or erythema were observed.Attempts were made to contact the healthcare provider (hcp) for additional clinical details regarding the event; however, no response was received.
Additional Manufacturer Narrative
Novocure's medical opinion is that the contribution of the arrays to the skin laceration cannot be ruled out.The fall, cerebral hemorrhage and seizure were unrelated to device use.Skin laceration is an expected event with optune gio device use (ef-11 0% and 1% ef-14 optune arm).

• 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: 23355007
• Report Number: 3010457505-2025-00605
• Device Sequence Number: 9202229
• Product Code: NZK
• UDI-Device Identifier: 07290107982207
• UDI-Public: (01)07290107982207(11)160419
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 10/22/2025

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: 09/26/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2016
• 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: ASPIRIN.; ATORVASTATIN.; CLOPIDOGREL BISULFATE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 58 KG