MAUDE Adverse Event Report: REBOUND THERAPEUTICS CORP AURORA SURGISCOPE 13CM; AURORA SURGISCOPE (US)

Catalog Number	AS8/130
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
A facility reported that the aurora surgiscope 13cm (as8/130) was used on a ich (intracerebral hemorrhage) procedure when the surgeon noted a message on the monitor, "camera overheating".The scope was removed and then replaced with a new 15 mm scope to continue the procedure.There was no delay nor patient injury reported.
Additional Manufacturer Narrative
The aurora surgiscope 13cm (as8/130) was returned for evaluation.Device history record (dhr): the 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 - the surgiscope was received with the obturator inserted.The obturator was removed for inspection.No obvious damage to the surgiscope or obturator was observed.The obturator tip had a reddish residue.There were also very slight signs of a reddish residue on the obturator handle, and camera mounting ring.The surgiscope upper and lower camera housings were removed to allow visual inspection of the camera pcb.There were no obvious signs of damage or corrosion on the camera pcb, solder connections of the coaxial cable to the pcb or the solder connections of the led wires to the pcb or led light tape.There was slight evidence of residue (spots) on the side surface of the upper camera housing.The lower camera housing inner surface was free of residue root cause - the reported complaint for the surgiscope was not confirmed.During the product return evaluation there were no functional or performance issues found with the returned surgiscope.

• Brand Name: AURORA SURGISCOPE 13CM
• Common Device Name: AURORA SURGISCOPE (US)
• Manufacturer (Section D): REBOUND THERAPEUTICS CORP; 13900 alton parkway; 13900 alton parkway; irvine CA
• Manufacturer (Section G): REBOUND THERAPEUTICS CORP; 13900 alton parkway; suite 120; irvine CA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18230064
• Report Number: 3015194982-2023-00008
• Device Sequence Number: 20386399
• Product Code: GWG
• UDI-Device Identifier: 00850002332131
• UDI-Public: 00850002332131
• Combination Product (Y/N): N
• PMA/510(K) Number: K191861
• 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
• Report Date (Section B): 04/11/2024

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: 07/28/2024
• Device Catalogue Number: AS8/130
• Device Lot Number: 6248708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2023
• Supplement Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown