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	06/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A 39-year-old male patient 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 was experiencing mild irritation at the surgical incision site, which remained slightly open.During a follow up appointment on (b)(6) 2026, it was noted that the patient tolerated optune gio well without skin side effects.An attempt was made to contact the prescribing physician; however, no reply was received.
Additional Manufacturer Narrative
Based on the available information, the contribution of the array placement to the wound dehiscence that might lead to a serious event, requiring medical and/or surgical intervention cannot be ruled out.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: prior radiation, underlying cancer disease, prior surgery affecting skin integrity.

• Brand Name: Optune Gio
• Common Device Name: Optune Gio
• Manufacturer (Section D): NOVOCURE GmbH; 21 neuhofstrasse; baar 6340 ; SZ 6340
• Manufacturer Contact: sharon perez ; 180 hanover street; portsmouth, NH ; +1(207)752-7602
• MDR Report Key: 50767402
• Report Number: 3010457505-2026-00857
• Device Sequence Number: 18529436
• Product Code: NZK
• UDI-Device Identifier: 07290107986427
• UDI-Public: (01)07290107986427(11)180315
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/15/2026

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
• Initial Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2018
• 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: 39 YR
• Patient Sex: Male