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	Post Operative Wound Infection (2446); Skin Inflammation/ Irritation (4545)
Date of Event	10/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A 34-year-old male patient with recurrent anaplastic astrocytoma began optune gio therapy on (b)(6), 2024.On (b)(6), 2024, the patient reported to novocure that he developed an ulcer at the surgical resection site scar.The patient consulted a healthcare provider (hcp), who advised a temporary discontinuation of optune gio therapy.On (b)(6), 2024, the patient indicated that therapy would remain paused for a few more weeks.No medical intervention was reported at that time.On (b)(6), 2025, novocure received a medical record documenting a neuro-oncology clinic visit on (b)(6), 2024.During this visit, the patient was noted to have an area of incomplete healing at the incision site, with intermittent serous drainage.Treatment included cephalexin 500 mg administered twice daily.On (b)(6), 2024, it was reported that the patient underwent a wound washout procedure for an infected surgical incision on (b)(6), 2024, followed by a cranioplasty on (b)(6), 2024.On (b)(6), 2025, the patient's spouse reported that the patient experienced skin irritation.The hcp again recommended a temporary discontinuation of optune gio therapy and prescribed an unspecified oral medication.Multiple attempts were made to obtain additional information from the prescribing physician although no reply was received.
Additional Manufacturer Narrative
Novocure's medical opinion is that the contribution of the transducer arrays to the wound infection and skin inflammation/irritation cannot be ruled out.Wound infection is an expected event with optune gio device use (ef-11 0% and <1% ef-14 optune arm).Contributing factors for wound infection in this patient include prior dexamethasone use (impaired wound healing and increased risk of infection are listed as side effects.Source: dexamethasone prescribing information), prior concomitant bevacizumab (carries a black box warning for wound complications.Source: bevacizumab prescribing information), prior radiation, chemotherapy, and prior surgery affecting skin integrity.Medical device site reaction is an expected event with optune gio device use (ef-11 16% and 53% 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: 22949895
• Report Number: 3010457505-2025-00576
• Device Sequence Number: 8260423
• Product Code: NZK
• UDI-Device Identifier: 07290107982207
• UDI-Public: (01)07290107982207(11)220519
• 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: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/03/2025

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: 01/21/2025
• Initial Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2022
• 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.; DEXAMETHASONE.; LEVETIRACETAM.; SERTRALINE.; VORASIDENIB.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR
• Patient Sex: Male
• Patient Weight: 91 KG