MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE GIO

Model Number TFH9100

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

Patient Problem Laceration(s) (1946)

Event Date 02/15/2024

Event Type  Injury  

Manufacturer Narrative

Novocure's medical opinion is that the contribution of the transducer arrays to the skin laceration cannot be ruled out.The fall was unrelated to device use.Skin laceration is an expected event with optune gio device use (ef-11 0% and 1% ef-14 optune arm).

Event Description

A 57-year-old male with recurrent glioblastoma (gbm) started optune gio therapy (b)(6), 2022.On february 15, 2024, novocure was informed by the patient that he fell and struck his head.Reportedly, patient's scalp got injured by one of the ceramic discs of the transducer array and he required sutures.Optune gio therapy was temporarily discontinued.The prescribing physician was contacted for further details without reply.

• Brand Name: OPTUNE GIO
• Type of Device: OPTUNE GIO
• Manufacturer (Section D): NOVOCURE GMBH; business village d4; park 6/platz 10; root d4, 6039 ; SZ 6039
• 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: 18885465
• MDR Text Key: 337430034
• Report Number: 3010457505-2024-00261
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: TFH9100
• Device Catalogue Number: TFH9100US
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/17/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: AMLODIPINE.; ATORVASTATIN.; CYANOCOBALAMIN.; DIVALPROEX.; LEVETIRACETAM.; LOMUSTINE.; OSIMERTINIB.
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 102 KG