MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA CLARITY CONSOLE

Catalog Number	C7000
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/24/2025
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 power on the cusa clarity console (c7000) was not working during a craniotomy procedure with tumor resection.The handpiece was dripping and they rebooted the device, but still the device was not ablating.There was a delay for around 20 to 30 minutes and there was unnecessary bleeding that occurred due to not being able to start getting the tumor out when the surgeon was ready; however, no injury was caused to the patient.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h4, h11.The cusa clarity console (c7000) was not returned for evaluation, and service was cancelled on this console.Device history record (dhr) review - lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.Failure analysis - from the information provided that the power was not working during the case, an integra technician facetimed with the customer and noticed the handpiece was also dripping.They changed the handpiece, checked the suction connection and cannister, restarted the device, cleared the tip and suctioned the fluid, then pressed the orange foot pedal.The amplitude was put all the way to 100 and the screen indicated the device was activating to the correct setting, but the surgeon said the device still was not ablating.It appears that there was a suction issue with the first handpiece which was rectified by clearing the tip and suctioning the fluid.It also indicates that a second handpiece was connected, and the console failed, which indicates that the root cause lay with the console.As a result, it was recommended that the customer follow the ¿operating the system¿ instruction from section 9 of the cusa clarity ifu.And if the issue persists, they are to contact integra to schedule a service.Root cause - due to the lack of information and evaluation, the root cause is undetermined.No relevant capas are pending/implemented, and no other actions have been identified relating to this issue.If the product is returned or additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: CUSA CLARITY CONSOLE
• Common Device Name: CUSA CLARITY
• Manufacturer (Section D): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 21380296
• Report Number: 3006697299-2025-00019
• Device Sequence Number: 21008840
• Product Code: LFL
• UDI-Device Identifier: 10381780126232
• UDI-Public: 10381780126232
• Combination Product (Y/N): N
• PMA/510(K) Number: K161882
• 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): 10/24/2025

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 Catalogue Number: C7000
• 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: 01/27/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2021
• 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