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	Wound Dehiscence (1154)
Date of Event	05/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A 68-year-old female patient with newly diagnosed glioblastoma (gbm) started optune gio therapy on (b)(6) 2025.On (b)(6) 2025, the patient's daughter reported to novocure that she observed an open sore near the patient's prior surgical resection site (last surgical resection (b)(6) 2024) upon removal of the transducer arrays.An image provided revealed a wound dehiscence at the site of the surgical resection scar, with exposed surgical hardware and associated mild to moderate erythema.Optune gio therapy was temporarily discontinued.Attempts to contact the prescribing physician for further details were made, but no response was received.
Additional Manufacturer Narrative
Novocure opinion is that the contribution of the array placement to the wound dehiscence cannot be ruled out.As this event might lead to a serious deterioration in the state of the health of the patient, this is assessed as a serious event.Contributing factors for wound dehiscence in this patient include: concomitant bevacizumab (vegf inhibitor which carries a black box warning for wound healing complications, source bevacizumab prescribing information), prior dexamethasone use (impaired wound healing and increased risk of infection are listed as side effects.Source: dexamethasone prescribing information), prior radiation, underlying cancer disease and prior surgery affecting skin integrity.Wound dehiscence is an expected event with optune gio device use (ef-11 0% and <1% ef-14 optune arm).
Additional Manufacturer Narrative
On (b)(6) 2025, the patient´s caregiver notified novocure that the patient was scheduled to undergo surgery on an unspecified date to repair an open wound with exposed bone that had not healed following a prior surgery to remove exposed hardware.It was noted that a plastic surgeon would be involved in the upcoming procedure.On (b)(6) 2025, the caregiver further informed novocure that the healthcare provider believed the patient was experiencing disease progression but also indicated that optune gio therapy could be resumed after surgical recovery.

• 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: 22076638
• Report Number: 3010457505-2025-00516
• Device Sequence Number: 18318499
• Product Code: NZK
• UDI-Device Identifier: 07290107982207
• UDI-Public: (01)07290107982207(11)160621
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2025

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Supplement Date Received by Manufacturer: 09/10/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2016
• 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.; ALBUTEROL.; APIXABAN.; BEVACIZUMAB.; DEXAMETHASONE.; LEVETIRACETAM.; ONDANSETRON.; PANTOPRAZOLE.; TEMOZOLOMIDE.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 68 YR
• Patient Sex: Female