MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LTD. CUSA CLARITY 36KHZ HANDPIECE

Catalog Number	C7036
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
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 cusa clarity 36khz handpiece (c7036) is defective and produced an error message during surgery.This incident increased the surgery time for 30 minutes.The surgery team used another equipment to finish the surgery.There was no patient injury.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The cusa clarity 36khz handpiece (c7036) was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - the investigation confirmed the reported incident.The handpiece generated "error 2304" and information such as operating hours cannot be read; therefore, replacement is required.As a result, the handpiece has been scrapped.Root cause - the root cause is confirmed as an eeprom error.This may result from a transient power loss or voltage fluctuation during active communication between the handpiece and the console.A review of all capas opened and investigated between 2024-2025 was completed and the review confirmed no capas associated with this root cause.Per the complaint evaluation performed, there was not an adverse trend identified, unacceptable individual risk, or a significant nonconformance to regulatory requirements.The issue will continue to be monitored through the complaint evaluation process.At present, we consider this complaint to be closed.

• Brand Name: CUSA CLARITY 36KHZ HANDPIECE
• Common Device Name: CUSA CLARITY
• 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: 23490845
• Report Number: 3006697299-2025-00127
• Device Sequence Number: 4732750
• Product Code: LFL
• UDI-Device Identifier: 10381780126263
• UDI-Public: 10381780126263
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2026

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: C7036
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2019
• 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