MAUDE Adverse Event Report: Integra NeuroSciences PR CUSA Clarity 36kHz Curved Extended MicroTip¿ (5 Pack); Tissue Ablation

Catalog Number	C7411S
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11 the cusa clarity 36khz curved extended microtip (c7411s) ) was not returned despite several requests; therefore, failure analysis is not possible.Additionally, no pictures have been provided, and there is no indication of imminent product return.Therefore, this alleged issue is unable to be confirmed and no root cause can be determined.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found during the packaging process that could contribute and/or be related to the reported condition.However, the cusa clarity ifu lists the warnings and cautions that could be related to the reported condition: ¿ when the handpiece is powered on, contact of the tip with a hard surface (for example: a metal instrument, tray, staples, clips, instruments, and so on) may damage the tip of the handpiece.¿ to avoid injury or damage to equipment, place system in standby prior to changing tip or clearing a clog.¿ avoid excessive lateral loading of cusa clarity tips.This may result in injury to the patient and/or user, or equipment damage.¿ when testing the handpiece, do not allow the tip to come in contact with any person or object during tip activation.Contact may result in injury to the patient and/or user, or handpiece tip damage.¿ to avoid product damage, always use the torque base to hold the handpiece while using the torque wrench to tighten or loosen the tip.Avoid over torqueing the tip.The root cause is most likely that one or more of the above warnings was not avoided.It was reported that it broke in the patient; however, any of these warnings could apply, since it could have been damaged in any of the aforementioned ways either prior to use in the patient or during use in the patient, then broken off ultimately in the patient.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 36kHz Curved Extended MicroTip¿ (5 Pack)
• Common Device Name: Tissue Ablation
• Manufacturer (Section D): Integra NeuroSciences PR; road 402 north, km 1.2; road 402 north, km 1.2; anasco PR 00610
• Manufacturer (Section G): Integra NeuroSciences PR; road 402 north, km 1.2; anasco PR 00610
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; +1(609)936-2319
• MDR Report Key: 50025489
• Report Number: 3006697299-2026-00063
• Device Sequence Number: 9662550
• Product Code: LFL
• UDI-Device Identifier: 10381780126355
• UDI-Public: 10381780126355
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161882
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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: C7411S
• Device Lot Number: 7650908
• 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: 07/02/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown