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	Bruise/Contusion (1754); Fall (1848); Laceration(s) (1946)
Date of Event	05/31/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure's medical opinion is that the contribution of device use to the fall and secondary skin laceration and contusion cannot be ruled out.Skin laceration is an expected event with optune gio device use (ef-11 0% and 1% ef-14 optune arm).Fall is an expected event with optune gio device use (ef-11 4% and 8% ef-14 optune arm).Contusion is an expected event with optune gio device use (ef-11 0% and 4% ef-14 optune arm).
Event or Problem Description
A 67-year-old female with newly diagnosed glioblastoma (gbm), started optune gio therapy on (b)(6) 2025.On (b)(6) 2026, the patient's spouse informed novocure that the patient experienced an unwitnessed fall on (b)(6) 2026, while attempting to get out of bed.The spouse noted that the patient was not wearing her non-slip socks, causing her feet to slip resulting in a fall.The patient struck her head on a headboard, sustaining a forehead laceration.She was transported to the emergency department (ed) and was subsequently admitted to the intensive care unit (icu) on (b)(6) 2026 and discharged on (b)(6) 2026.Optune gio therapy was temporarily discontinued.According to the patient, she had risen from bed while wearing the transducer arrays on the scalp, disconnected from the device, and tripped over the device connector cable.On (b)(6) 2026, the prescribing physician reported that the patient experienced an accidental fall after tripping.The patient sustained a small area of skin bruising, and optune gio therapy was resumed with transducer array repositioning.The prescriber also noted that the patient had been evaluated at an outside hospital; however, the physician had not personally examined the patient.The physician assessed the cause of the event as unrelated to optune gio therapy.In the patient¿s available medical record dated (b)(6) 2026, it was noted that the patient experienced muscular weakness in both the upper and lower extremities and used a cane for ambulation.

• Brand Name: OPTUNE GIO
• Common Device Name: OPTUNE GIO
• Manufacturer (Section D): NOVOCURE GMBH
• Manufacturer Contact: sharon perez ; 21 neuhofstrasse; baar 6340 ; CH 6340 ; 60331
• MDR Report Key: 25634466
• Report Number: 3010457505-2026-00785
• Device Sequence Number: 9735746
• Product Code: NZK
• UDI-Device Identifier: 07290107986427
• UDI-Public: (01)07290107986427(11)160714
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P100034/S033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2026

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
• Device Lot Number: N/A
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2016
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female