MAUDE Adverse Event Report: REBOUND THERAPEUTICS CORP SURGISCOPE 9MM X 100MM; AURORA SURGISCOPE SYSTEM

Catalog Number	ASX9/100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	09/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Study: product: asx9/100 - aurora surgiscope system.Serial number: (b)(6) study procedure date: (b)(6)2024.Adverse event (ae): seizure.Ae detail: ¿seizure like activity, unresponsive, slumped over/chin down, hypotensive and bradycardiac¿ ae onset date: (b)(6)2024.Is the ae serious: yes.Ae severity: severe.Did it result in death of the subject: no.Is the ae life-threatening: yes.Did the ae result in an initial or prolonged hospitalization: yes.Did the ae require intervention to prevent permanent impairment or damage: yes.Hospital admission date: (b)(6)2024.Action taken: medication, hospitalization without surgery.Ae resolution/end date: pending.Principal investigator assessment: relationship to device - possible.Principal investigator assessment: relationship to the procedure- possible.Expectedness: anticipated.Additional information received: "anytime we use a device in the brain it is possible it can cause a seizure.No issues with device¿.
Additional Manufacturer Narrative
The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Additional information received: the principal investigator has updated the correlation of the ae to the device and procedure to "not related" to study device.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.No product was returned to be evaluated; therefore, no failure analysis was performed.However it should be noted that the complainant was asked if there was a malfunction of the device that caused the seizure; the complainant replied: ¿no issues with device¿.Therefore, based on the complainant¿s response, there are no device failures or product quality issues to analyze in this complaint.
Event or Problem Description
N/a.

• Brand Name: SURGISCOPE 9MM X 100MM
• Common Device Name: AURORA SURGISCOPE SYSTEM
• Manufacturer (Section D): REBOUND THERAPEUTICS CORP; 13900 alton parkway; 13900 alton parkway; irvine CA 92618
• Manufacturer (Section G): REBOUND THERAPEUTICS CORP; 13900 alton parkway; suite 120; irvine CA 92618
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 21078358
• Report Number: 3013505638-2024-00005
• Device Sequence Number: 8386622
• Product Code: GWG
• UDI-Device Identifier: 00850002332285
• UDI-Public: 00850002332285
• Combination Product (Y/N): N
• PMA/510(K) Number: K232618
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2025

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: Health Professional
• Device Expiration Date: 02/28/2025
• Device Catalogue Number: ASX9/100
• Device Lot Number: 7383228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 02/05/2025; 06/11/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 02/27/2025; 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Other
• Patient Sex: Unknown