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

Catalog Number	C7000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This is 2 of 2 reports for the concomitant cusa clarity console (c7000), and linked to mfg report number 3006697299-2025-00046: a facility reported that during a surgical procedure for transsphenoidal microadenoma resection, the specialist began using the aspirator and stated that the tip felt too hot.This was confirmed by the surgical consultant, who noted that the tip felt hot, but the handpiece was at a normal temperature.The parameters on the screen were checked and were: amplitude: 80, aspiration: 100, fluid: 3 , select tissue: low.Additional information received as follows: 1.Patient's condition: stable, no complications.2.Was the surgery successful? yes, the surgery was successful.3.Did the patient require further medical attention or surgery? no.4.There is a comment: "i also want to report that this is the second time this type of heating has occurred." was it the same handpiece or a different one? the incident occurred with the same equipment and the same handpiece.5.Was a complaint filed for the previous case? no, the first situation was not formally reported to complaints.The biomedical department tested the equipment, and it worked properly, and there were no new developments.Since this is the second time, we feel it is important to report it for follow-up.
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.
Additional Manufacturer Narrative
Updated fields: b3, g3, g6, h2, h11.Additional information was received as follows: 1.What is the date of the first heating incident? answer: the date of the first heating incident for the c7415s tip was (b)(6) 2024.2.Was there any injury to the patient? if so, what type of injury? answer: no patient was involved.3.Did the patient require any additional medical or surgical intervention? answer: no patient was involved.4.Was there a surgical delay due to heating? answer: no patient was involved.5.What was the patient's progress? answer: no patient was involved.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The cusa clarity console (c7000) was not returned for evaluation after three good faith attempts (gfes) were made.Serial number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The device was not returned however, photographs were provided, which appear to show evidence consistent with the reported handpiece tip overheating and damage to the equipment cable.Based on the description of the incident indicating that the tip became excessively hot, it can be concluded that the root cause was associated with the tip from the handpiece that was attached to this console.A possible root cause may be due to, (from cusa clarity ifu).Cusa clarity tips utilize a silicone flue.Compressing the flue against the side of the vibrating surface along the length of the tip may cause excessive heating, which may burn the adjacent tissue of the surgical site.Excessive loading of cusa clarity tips at the surgical site may induce heating due to vibration and acoustic power transmissions.Thermal management of the surgical site with the aid of the appropriate irrigation and aspiration settings is essential.If 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: 21934100
• Report Number: 3006697299-2025-00048
• Device Sequence Number: 12101269
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2025

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: 04/03/2025
• Supplement Date Received by Manufacturer: 05/08/2025; 10/13/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 06/04/2025; 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CUSA CLARITY 36KHZ MICROTIP (C7415S).
• Patient Sex: Unknown