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	Laceration(s) (1946)
Date of Event	01/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure´s medical opinion is that the contribution of the transducer arrays to the skin laceration cannot be ruled out.The fall and exacerbation of chronic left shoulder subluxation were 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 or Problem Description
A 49-year-old female with recurrent glioblastoma (gbm) started optune gio therapy (b)(6) 2023.On january 13, 2024, novocure was informed by the patient that she fell forward while using the bathroom, hitting the head on a doorframe.Patient was subsequently admitted to the emergency department.The patient denied loss of consciousness, headache and blurred vision.The fall resulted in a 3 cm abrasion with 0.25 cm skin laceration.The patient was wearing optune gio device during the fall.Reportedly, one of the electrodes broke and contributed to the skin laceration.The skin laceration was closed with medical glue and patient discharged to home in stable condition the same day.Additionally, patient endorsed exacerbation of chronic left shoulder pain, following the fall.The prescribing physician was contacted, but did not provide a causality assessment.

• Brand Name: OPTUNE GIO
• Common Device Name: 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: 18666736
• Report Number: 3010457505-2024-00258
• Device Sequence Number: 20961915
• Product Code: NZK
• UDI-Device Identifier: 07290107982221
• UDI-Public: 07290107982221
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 02/08/2024

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2024
• Initial Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2016
• 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: ABEMACICLIB; BACLOFEN; BEVACIZUMAB; DEXAMETHASONE; L-THEANINE; LACOSAMIDE; LISINOPRIL; MELATONIN; MIRABEGRON; ONDANSETRONE; TEMOZOLOMIDE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female