MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) EXCEL 36KHZ STRAIGHT HANDPIECE EACH1; ULTRASONIC SURGICAL PRODUCTS

Catalog Number	C2602
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 reflux circulation was not working on the cusa excel 36khz straight handpiece (c2602), and the device became hot.There was no patient or user injury or surgical delay.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The mayfield modified skull clamp (a1059) was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - the investigation of the returned handpiece (hp) shows that the flow rate of cooling water is decreasing due to the narrowing of the flow path due to the aging and twisting of the cable.The coil foam has also deteriorated over time, there is metal deterioration, and there is a high possibility that it will break in the future.Asa result, the cable and coil foam will be replaced as a set.In addition, it was confirmed that the shaft misalignment occurred due to overtorque of the hp during insertion and detachment.The inside of the housing (resin part of the handle) is scraped and damaged due to shaft misalignment, so the housing needs to be replaced.Root cause - the root cause is confirmed as "incorrect assembly and disassembly of the handpiece by the customer when using the torque wrench resulting in torque wrench misaligning the dot on the hp and the handpiece connector.Additionally, during servicing, it was confirmed that the cooling water flow rate had decreased due to narrowing of the flow path, attributed to cable aging, twisting, and general wear over time.The restricted cooling water flow resulted in overheating of the handpiece.A review of the service history indicated that this was the first service performed in 13 years, suggesting that preventive maintenance is overdue.Regular maintenance is essential to prevent handpiece related issues and to ensure consistent, reliable performance.Furthermore, the coilform exhibited signs of deterioration consistent with wear and tear after 13 years in operation.A corrective and preventative action (capa) has been raised to investigate this issue and is pending corrective action.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: EXCEL 36KHZ STRAIGHT HANDPIECE EACH1
• 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: 23110150
• Report Number: 3006697299-2025-00111
• Device Sequence Number: 13219630
• 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): 11/10/2025

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
• Device Lot Number: 2152471
• 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: 08/28/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 09/22/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2012
• 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