MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA CUSA EXCEL 36KHZ STRAIGHT HANDPIECE; ULTRASONIC SURGICAL PRODUCTS

Catalog Number	C2602
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported that the cusa excel 36khz straight handpiece (c2602) overheated during surgery and the nurse was burnt.Additional information received: 1.Did the problem occur before an operation (patient prepared/under anesthesia)? during an operation? at the end of an operation? answer: the problem occurred during the operation.2.Did the problem cause an increase in the duration of the procedure (= or > 30 minutes)? answer: according to the information provided, this did not increase the duration by more than or equal to 30 minutes.3.Did this incident have any consequences for the patient? if so, what were they? answer: no, no incident for the patient.4.Was another device available to complete the surgical procedure? answer: the same device was used from start to finish.5.If applicable: did the problem cause smoke, fire, and/or burns? answer: yes, the problem caused a minor burn to a nurse.6.What were the cusa parameter settings? - amplitude.- suction.- irrigation.- tissue select.Answer: i don't have this information; the only information on this is that the handpiece was very hot from start to finish.The device was tested at our facility but did not heat 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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The excel 36khz straight handpiece each1 (c2602) was not returned; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.Based on the complaint of "overheating" and the description details, "i don't have this information; the only information on this is that the handpiece was very hot from start to finish.The device was tested at our facility but did not heat up." therefore, the error may have occurred due to insufficient cooling water in the console reservoir, resulting in the handpiece not cooling during use as there is not enough fluid passing through to keep the handpiece temperature lower when in use.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 EXCEL 36KHZ STRAIGHT HANDPIECE
• Common Device Name: ULTRASONIC SURGICAL PRODUCTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 23544286
• Report Number: 3006697299-2025-00129
• Device Sequence Number: 9609470
• Product Code: LFL
• UDI-Device Identifier: 10381780039433
• UDI-Public: 10381780039433
• Combination Product (Y/N): N
• PMA/510(K) Number: K141674
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: C2602
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown