MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE GIO

Model Number TFH9100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Date 12/29/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 333194935
• Report Number: 3010457505-2024-00254
• Device Sequence Number: 1
• Product Code: NZK
• UDI-Device Identifier: 07290107982221
• UDI-Public: 07290107982221
• Combination Product (y/n): N
• PMA/PMN Number: P100034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: TFH9100
• Device Catalogue Number: TFH9100US
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention