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	Impaired Healing (2378)
Date of Event	05/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure opinion is that the contribution of the array placement to the impaired wound healing cannot be ruled out.Contributing factors for impaired healing in this patient include prior radiation, chemotherapy, and prior surgery affecting skin integrity.Impaired healing is an expected event with optune gio device use (ef-11 0% and <1% ef-14 optune arm).
Event or Problem Description
A 33-year-old female patient with newly diagnosed glioblastoma (gbm) began optune gio therapy on (b)(6) 2022.On (b)(6) 2025, novocure was notified that the patient had an appointment with their healthcare provider (hcp) on that date due to unspecified findings on a prior mri scan and to plan for surgery scheduled on (b)(6) 2025.As a result, optune gio therapy was temporarily discontinued.On (b)(6) 2025, the patient's caregiver reported that the patient visited the hcp for suture removal.On (b)(6) 2025, novocure was informed that the patient had resumed optune gio therapy on (b)(6) 2025.Additionally, the patient underwent an evaluation at the hospital due to drainage observed near the surgical resection site.No further clinical details were provided.Multiple attempts were made to contact the prescribing physician; however, no response was received.

• Brand Name: OPTUNE GIO
• Common Device Name: OPTUNE GIO
• Manufacturer (Section D): NOVOCURE GMBH; neuhofstrasse 21; baar, 6340 ; SZ 6340
• Manufacturer (Section G): NOVOCURE GMBH; neuhofstrasse 21; baar, 6340 ; SZ 6340
• Manufacturer Contact: sharon perez ; 180 hanover st.; portsmouth, NH 03801 ; 2077527602
• MDR Report Key: 22138995
• Report Number: 3010457505-2025-00520
• Device Sequence Number: 17980895
• Product Code: NZK
• UDI-Device Identifier: 07290107982207
• UDI-Public: (01)07290107982207(11)160819
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P100034
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/04/2025

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ACETAMINOPHEN; BETAMETHASONE DIPROPIONATE; CHOLECALCIFEROL; CLINDAMYCIN PHOSPHATE; CLOBAZAM; CLOBETASOL; FELBAMATE; FLUTICASONE PROPIONATE; LEVOCETIRIZINE DIHYDROCHLORIDE; LEVONORGESTREL; LEVOTHYROXINE SODIUM; LISDEXAMFETAMINE DIMESYLATE; MELATONIN; OMEPRAZOLE; QUETIAPINE FUMARATE; SENNOSIDES/DOCUSATE SODIUM; SOLIFENACIN SUCCINATE; TRAZODONE; ZONISAMIDE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 97 KG