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	05/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A 56-year-old female with newly diagnosed glioblastoma (gbm) started optune gio (b)(6) 2026.On (b)(6) 2026, the patient¿s caregiver informed novocure that the patient had been admitted to the hospital on (b)(6) 2026, due to a surgical resection site infection requiring a surgical procedure for infection debridement.The patient was expected to remain hospitalized for an additional three days and temporarily discontinued optune gio therapy until removal of the post-surgical sutures.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 ; 2077527602
• MDR Report Key: 25499861
• Report Number: 3010457505-2026-00760
• Device Sequence Number: 10505958
• Product Code: NZK
• UDI-Device Identifier: 07290107986427
• UDI-Public: (01)07290107986427(11)160721
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2026

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female