MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA CLARITY 36KHZ CURVED EXTENDED MICROTIP¿ PLUS (5 PACK)

Catalog Number	C7415S
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This is 1 of 2 reports linked to mfg report number 3006697299-2025-00042: a facility reported that during a surgical procedure for transsphenoidal microadenoma resection, the specialist began using the aspirator and stated that the cusa clarity 36khz curved extended microtip (c7415s) 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: d4, d9, g3, g6, h2, h3, h4, h6, h11.The c7415s cusa clarity 36khz curved extended microtip¿ plus was not returned; however lot number information has been provided; therefore, the device history record (dhr) was reviewed and found no anomalies.Failure analysis & root cause - according to the customer, the product will not be returned, since this is for a previously alleged overheating incident that was never reported to integra at the time.The second alleged overheating incident investigation is on mfg report number 3006697299-2025-00045.Customer subsequently reported that no patient was involved in this initial incident, and that it occurred on (b)(6) 2024.Since the product has not been returned, no pictures were provided, and this is from an incident that occurred last year, this complaint cannot be further investigated or confirmed.The root cause determination for this alleged overheating issue is not possible, as the product has not returned for evaluation.No relevant capas were discovered, and no other actions have been identified relating to this issue, and no manufacturing, workmanship, or material deficiency was identified for correction as a result of this complaint investigation.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 36KHZ CURVED EXTENDED MICROTIP¿ PLUS (5 PACK)
• 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: 21934033
• Report Number: 3006697299-2025-00046
• Device Sequence Number: 18102344
• Product Code: LFL
• UDI-Device Identifier: 10381780126379
• UDI-Public: 10381780126379
• 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): 06/20/2025

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: C7415S
• Device Lot Number: 7343144
• 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: 06/04/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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