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	12/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure opinion is that the contribution of the array placement to 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).
Event or Problem Description
On (b)(6) 2023, novocure received the reply regarding an anonymous patient survey conducted in the united states by an agency on behalf of novocure.In the survey, the unknown patient reported that they experienced a wound infection at the surgical resection site.The event required additional surgery that included a "clean-out" and removal of the skull plate.Date of event is unknown.Optune gio therapy was discontinued.No additional information is available, customer cannot be identified.

• Brand Name: OPTUNE GIO
• Common Device Name: OPTUNE GIO
• Manufacturer (Section G): NOVOCURE GMBH; business village d4; park 6/platz 10; root d4, 6039 ; SZ 6039
• Manufacturer Contact: sharon perez ; 195 commerce way; portsmouth, NH 03801 ; 2077527602
• MDR Report Key: 18541194
• Report Number: 3010457505-2024-00254
• Device Sequence Number: 8903165
• Product Code: NZK
• UDI-Device Identifier: 07290107982221
• UDI-Public: 07290107982221
• Combination Product (Y/N): N
• 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): 01/19/2024

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: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2023
• Initial Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown