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	11/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure's medical opinion is that the contribution of the arrays to the skin laceration cannot be ruled out.The fall was unrelated to device use.Skin laceration is an expected event with optune gio device use (ef-11 0% and 1% ef-14 optune arm).
Event or Problem Description
A 51-year-old female patient with newly diagnosed glioblastoma (gbm) began optune gio therapy on (b)(6) 2023.On (b)(6) 2025, the patient informed novocure that on the previous day she had fallen down the stairs while on optune gio therapy and sustained a scalp laceration requiring sutures.The patient temporarily discontinued optune gio therapy.Multiple attempts were made to contact the prescribing physician for further information, although no reply was received.
Additional Manufacturer Narrative
On december 12, 2025, the prescribing physician reported that the patient did not sustain any injuries as a result of the fall and was not hospitalized.Optune gio therapy had been temporarily discontinued; however, therapy had resumed at the time of the report.According to the prescriber, the event was not related to optune gio therapy.

• 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: 23739983
• Report Number: 3010457505-2025-00643
• Device Sequence Number: 13314373
• Product Code: NZK
• UDI-Device Identifier: 07290107982207
• UDI-Public: (01)07290107982207(11)171002
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2017
• 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: CLOBETASOL; HYDROCHLOROTHIAZIDE; LACOSAMIDE; LEVETIRACETAM; LISINOPRIL; MIDAZOLAM; SENNA GLYCOSIDE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female