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	05/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure¿s medical opinion is that the contribution of the transducer arrays to the wound dehiscence cannot be ruled out.As this event might have led to a serious deterioration in the state of the health of the patient, this is assessed as serious.Wound dehiscence is an expected event with optune gio device use (ef-11 0% and <1% ef-14 optune arm).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.
Event or Problem Description
A 74-year-old female with newly diagnosed glioblastoma (gbm) started optune gio therapy on (b)(6) 2026.On (b)(6) 2026, novocure received a medical record dated (b)(6) 2026, indicating that the patient experienced a wound dehiscence.Based on the available information, it was unclear whether the event was caused by trauma related to the transducer arrays removal or associated with bevacizumab.The dermatologist reportedly suspected the former.The patient applied bacitracin to the wound as recommended by a dermatologist and repositioned the arrays to avoid the irritated area.An attempt was made to contact the prescribing physician; however, no reply was received.

• 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: 25503842
• Report Number: 3010457505-2026-00759
• Device Sequence Number: 10501791
• Product Code: NZK
• UDI-Device Identifier: 07290107986427
• UDI-Public: (01)07290107986427(11)161108
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional
• Initial Reporter Occupation: Physician
• 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
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• 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
• Date Device Manufactured: 08/19/2021
• 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: Other
• Patient Age: 74 YR
• Patient Sex: Female