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

Catalog Number	C7000
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
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
A facility reported that during intracranial malignant tumor removal surgery, the cusa clarity console (c7000) displayed an error message when turning on the device.The device was turned off, and then turned back on after unplugging it for 15 minutes but there was no sign of improvement.Another device was used to complete the surgery.A cem nosecone was not used when the error occurred.Also, a specific placement of a generator from the device is unknown, though a generator was placed in the same room.There was more than 30 minutes of surgical delay; however no adverse consequences to the patient were observed.
Additional Manufacturer Narrative
Updated fields: the cusa clarity console (c7000) was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - investigation of the returned device showed that an error occurred and same was confirmed in the error history in the operation log.This error was caused by poor communication between the boards, and we confirmed that the error was resolved by reinstalling the software.As a function check, we performed an amplitude test, an irrigation motor rpm check, a suction pressure measurement, and a foot switch check, and confirmed that there were no problems.We have confirmed that the irrigation door does not open and close smoothly (it is stiff) and confirmed there was damage to the ac cord insertion area (fuse drawer).As this may lead to new malfunctions, we are recommending that regular inspections, including repairs and replacement of regularly replaced parts be considered.Root cause - the root cause is confirmed as time out errors and irrigation subassembly & damage.A capa has been raised to investigate "error code displayed on clarity console" and is pending corrective action, if necessary.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• 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: 20544601
• Report Number: 3006697299-2024-00161
• Device Sequence Number: 18025393
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2022
• 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