MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LTD. CUSA CLARITY CONSOLE; TISSUE ABLATION

Catalog Number	C7000
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2025
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
This is 1 of 4 reports for the console (b)(6) used in surgery on (b)(6) 2025, and linked to mfg report nos: 3006697299-2026-00003, 3006697299-2026-00004, 3006697299-2026-00005.A facility reported multiple touchscreen malfunctions were reported on two consoles (b)(6).The touchscreen intermittently froze during surgical procedures, preventing the operator from adjusting settings.The failures occurred across multiple patients and multiple procedures.A temporary recovery was consistently achieved by turning the device off and on, which restored touch functionality for a limited period.Both consoles were used alternately depending on which one was functioning at a given moment.The issue experienced by the customer led to increased surgery time of approximately 45 minutes.However, the surgeries were continued and completed in the manner described above.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11 the cusa clarity console (c7000) was evaluated: device history record (dhr) - the dhr was reviewed, and no anomalies were observed during manufacture or packaging that could be associated with the complaint incident.Failure analysis - the reported failure "touch screen failure" was confirmed during field service.Root cause - a corrective and preventative action (capa) is currently open relating to frozen screen on clarity consoles and the root cause is under investigation.
Event or Problem Description
N/a.

• Brand Name: CUSA CLARITY CONSOLE
• Common Device Name: TISSUE ABLATION
• Manufacturer (Section D): INTEGRA LIFESCIENCES (IRELAND) LTD.; sragh tullamore, co. offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES (IRELAND) LTD.; sragh tullamore, co. offaly ; EI
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 24208962
• Report Number: 3006697299-2026-00002
• Device Sequence Number: 14823659
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2026

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 02/25/2026; 06/09/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 03/13/2026; 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2017
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3003418325/03062026/C/01
• Patient Sequence Number: 1
• Patient Sex: Unknown