MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA EXCEL 36KHZ STRAIGHT HANDPIECE; ULTRASONIC SURGICAL PRODUCTS

Catalog Number	C2602
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/21/2024
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 handle on the cusa excel 36khz straight handpiece (c2602) was very hot.No information on patient involvement or surgical delay has been provided.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The cusa excel 36khz straight handpiece (c2602) was returned for evaluation: device history record (dhr) ¿ the dhr was reviewed and no anomalies that could be associated with the complaint incident was observed.Failure analysis - the investigation of the unit was unable to confirm the reported issue.No fault was found, and the device passed all cosmetic and functional testing and meets specification.No issue was determined.However, it was observed that annual preventive maintenance (pm) was overdue.Consistent maintenance extends the lifespan of the handpiece and maintains its proper function.Our records show that this product has been in the field for 8 years with a history of one annual services.Root cause - the complaint is unconfirmed, and the device meet specifications.However, based on reported failure of, handle is very hot, per the cusa excel ifu, it is possible this issue is most likely due to: a pinch or kink in the handpiece cable, causing a blockage in the irrigation cooling flow; or no irrigation flow from the handpiece flue.No further investigation is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: CUSA EXCEL 36KHZ STRAIGHT HANDPIECE
• Common Device Name: ULTRASONIC SURGICAL PRODUCTS
• 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: 21027327
• Report Number: 3006697299-2024-00180
• Device Sequence Number: 9046119
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

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: C2602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2017
• 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