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	Post Operative Wound Infection (2446)
Date of Event	08/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A 63-year-old female patient with newly diagnosed glioblastoma (gbm) began optune gio therapy on (b)(6) 2026.On (b)(6) 2026, the patient's daughter informed novocure that the patient had temporarily discontinued optune gio therapy the previous day due to a wound described as a small scab with an underlying fluid collection at the surgical incision site.On august 17, 2026, additional information was received indicating that the surgical incision had become infected.The patient was treated with unspecified antibiotics and temporarily discontinued optune gio therapy following the recommendation of the healthcare provider.On (b)(6) 2026, novocure received a medical record dated (b)(6) 2026, indicating that the patient had completed a one-week course of amoxicillin and doxycycline for drainage from the surgical site.At the time of the appointment, yellow drainage was still present; however, it had improved, and the patient was applying bacitracin and using bandages.The patient's family reported that the patient frequently touched the wound.Additionally, temozolomide therapy had been temporarily discontinued to support wound healing.Multiple attempts were made to contact the prescribing physician; however, no reply was received.
Additional Manufacturer Narrative
Novocure¿s medical opinion is that the contribution of the transducer arrays to the wound infection 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 radiation, underlying cancer disease and prior surgery affecting skin integrity.

• Brand Name: Optune Gio
• Common Device Name: Optune Gio
• Manufacturer (Section D): NOVOCURE GmbH
• Manufacturer Contact: sharon perez ; 180 hanover street; portsmouth, NH ; +1(207)752-7602
• MDR Report Key: 50712596
• Report Number: 3010457505-2026-00854
• Device Sequence Number: 10640439
• Product Code: NZK
• UDI-Device Identifier: 07290107986427
• UDI-Public: (01)07290107986427(11)160623
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/10/2026

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
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2016
• 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: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female