MAUDE Adverse Event Report: REBOUND THERAPEUTICS CORP AURORA EVACUATOR + COAG 100MM

Catalog Number	AEC12F/100
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
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
This is 1 of 3 reports linked to mfg report numbers: 3013505638-2024-00002.3013505638-2024-00003.A facility reported an aurora evacuator (id aec12f/100) was used on a ich (intracerebral hemorrhage) evacuation procedure when it clogged and the bipolar did not work.They had to open three scopes and switch to regular bipolars.The evacuator got clogged and the bipolar did not work.The event led to 30 minutes surgical delay, however, there was no adverse consequences due to the delay.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The aurora evacuator + coag 100mm (aec12f/100) 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 complaint stated that ¿the evac with coag got clogged¿.As returned, the evacuator +coag had residue on the handle and vacuum barb fitting.There was also black/red debris in the wand window and on the whisk paddle indicating that build-up of tissue within the vacuum lumen had occurred during the procedure.As returned the debris in the lumen had dried, possibly resulting in a patent vacuum lumen.The returned unit shows tissue build up that could have resulted in diminished functionality during the case.The complaint also stated that the ¿bipolar did not work¿.As returned, there was no indication of excess build-up of material on either the bipolar electrodes or connector prongs.Additionally, the integrity of the bipolar system was verified with a continuity check from the bipolar connector prongs at the proximal end to the bipolar electrodes at the distal end of the evacuator +coag.As returned, there were no signs of defects to the bipolar system of the evacuator +coag.Root cause - no assignable root cause could be identified.Regarding the complaint statement that ¿the evac with coag got clogged¿ the return product showed debris in the lumen had dried, possibly resulting in a patent vacuum lumen.The returned unit shows tissue build up and that could have resulted in diminished functionally during the case.Regarding the complaint statement that the ¿bipolar did not work¿ the returned product showed no indication of excess build-up of material on either the bipolar electrodes or connector prongs.The integrity of the bipolar system was verified with a continuity check from the bipolar connector prongs at the proximal end to the bipolar electrodes at the distal end of the evacuator +coag.As returned, there were no signs of defects to the bipolar system of the evacuator +coag.
Event or Problem Description
N/a.

• Brand Name: AURORA EVACUATOR + COAG 100MM
• Common Device Name: AURORA EVACUATOR
• 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: 20212941
• Report Number: 3013505638-2024-00001
• Device Sequence Number: 7494211
• Product Code: GEI
• UDI-Device Identifier: 00850002332216
• UDI-Public: 00850002332216
• Combination Product (Y/N): N
• PMA/510(K) Number: K203745
• 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): 02/06/2025

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: AEC12F/100
• Device Lot Number: 7378207
• 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: 01/20/2025
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2024
• 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