MAUDE Adverse Event Report: REBOUND THERAPEUTICS CORP SURGISCOPE 15MM X 80MM; AURORA SURGISCOPE SYSTEM

Catalog Number	ASX15/80
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This is 2 of 3 reports linked to mfg report numbers: 3013505638-2024-00001, 3013505638-2024-00003.A facility reported an aurora evacuator (id asx15/80) was used on a ich (intracerebral hemorrhage) evacuation procedure when the scope's camera was extremely blurry from water getting into camera and lost proper visualization.The event led to 30 minutes surgical delay; however, no patient consequences reported.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h11.Additional information received: the camera experienced issue due to the placement of the tube and irrigation.The angle of the tube put the camera on the downside of the opening of the tube.The surgeon used a bulb irrigator and put water into the camera system.We have since retrained the operative room (or) nursing team, surgeons and physician assistants (pa).
Additional Manufacturer Narrative
Updated fields: d4(udi#), d9, g3, g6, h2, h3, h6, h11.The surgiscope 15mm x 80mm (asx15/80) was returned for evaluation.Device history record (dhr) review was completed, and no anomalies occurred during the manufacturing or packaging of the device that could be attributed to the complaint.Failure analysis - although the initial image from all the imager was out of focus, there were no functional or performance issues found with the imager.Product development was able to bring the target image into focus with the imager; the target image was focused and not foggy or hazy.Root cause - the reported complaint and complaint sample evaluation indicate that the blurry images observed by customer were due to water ingress (i.E.Known user error) and failure to adjust the focus knob (note: product development evaluation found the focus knob to be properly functioning with no damage noted).
Event or Problem Description
N/a.

• Brand Name: SURGISCOPE 15MM X 80MM
• 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: 20212846
• Report Number: 3013505638-2024-00002
• Device Sequence Number: 7202100
• Product Code: GZT
• UDI-Device Identifier: 00850002332247
• UDI-Public: 00850002332247
• Combination Product (Y/N): N
• PMA/510(K) Number: K201840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2025
• Device Catalogue Number: ASX15/80
• Device Lot Number: 735877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2024
• Supplement Date Received by Manufacturer: 03/24/2025; 05/28/2025
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 04/22/2025; 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2024
• 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
• Patient Sex: Unknown