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	Bone Fracture(s) (1870)
Date of Event	06/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A 71-year-old female patient with newly diagnosed glioblastoma (gbm) started optune gio therapy on (b)(6) 2024.On (b)(6) 2025, the patient informed novocure that, approximately two weeks prior, she placed the device on the bathroom sink and the device subsequently fell onto her foot, resulting in fractures to two bones.The patient believed that the weight of the device was the cause of the injury.The patient went to the emergency room (er) and was given a foot brace.The patient remained on optune gio therapy.The patient's prescribing physician was contacted for additional information, although no reply was received.
Additional Manufacturer Narrative
Novocure's medical opinion is that the contribution of the optune gio device to the foot fracture cannot be ruled out.Foot fracture 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: 22554177
• Report Number: 3010457505-2025-00540
• Device Sequence Number: 9559433
• Product Code: NZK
• UDI-Device Identifier: 07290107982207
• UDI-Public: (01)07290107982207(11)160814
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2025

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: 06/25/2025
• Initial Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2016
• 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: ACETAMINOPHEN; CALCIUM-CHOLECALCIFEROL; CYANOCOBALAMIN; MAGNESIUM HYDROXIDE; ONDANSETRON
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 57 KG