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	Spinal deformity (4886)
Date of Event	07/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure medical opinion is that the contribution of device use to the patient's temporary impairment due to kyphosis which required physical therapy cannot be ruled out.Kyphosis is an expected event with optune gio device use (ef-11 0% and <1% ef-14 optune arm).
Event or Problem Description
A 71-year-old male patient with newly diagnosed glioblastoma (gbm) started optune gio therapy on (b)(6) 2023.On (b)(6) 2025, novocure received a medical record, indicating that the patient developed a hunched posture, attributed to prolonged use of optune gio therapy exceeding 18 hours per day.It was also noted that the patient had chronic right sided weakness.The patient was referred to physical therapy and continued the use of optune gio therapy.Several attempts were made to contact the prescribing physician for additional information, although no reply 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: 22882232
• Report Number: 3010457505-2025-00575
• Device Sequence Number: 13171887
• Product Code: NZK
• UDI-Device Identifier: 07290107982207
• UDI-Public: (01)07290107982207(11)160410
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/25/2025

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: 08/12/2025
• Initial Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2016
• 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: BACLOFEN.; BETAMETHASONE DIPROPIONATE OINTMENT.; CICLOPIROX TOPICAL OINTMENT.; LEVETIRACETAM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male