MAUDE Adverse Event Report: NOVOCURE GmbH Optune Gio; Stimulator, Low Electric Field, Tumor Treatment

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	07/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On august 19, 2026, novocure received a response from the hcp indicating that the patient was not hospitalized and did not require any treatment for the reported event.According to the physician, there were no signs of wound dehiscence or infection.The physician further assessed that the event was not related to optune gio therapy, and the patient continued treatment.

• Brand Name: Optune Gio
• Common Device Name: Stimulator, Low Electric Field, Tumor Treatment
• Manufacturer (Section D): NOVOCURE GmbH
• Manufacturer Contact: sharon perez ; 180 hanover street; portsmouth, NH ; +1(207)752-7602
• MDR Report Key: 50155879
• Report Number: 3010457505-2026-00826
• Device Sequence Number: 13034553
• Product Code: NZK
• UDI-Device Identifier: 07290107986427
• UDI-Public: (01)07290107986427(11)160821
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• 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?: No
• Initial Date Received by Manufacturer: 07/14/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2016
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Male