MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) EXCEL 23KHZ STRAIGHT HANDPIECE C2600P; TISSUE ABLATION

Catalog Number	C2600P
Medical Device Problem Codes	Crack (1135); Overheating of Device (1437)
Health Effect - Clinical Code	Insufficient Information (4580)
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 a loaner cusa excel 23khz straight handpiece (c2600) is cracked and overheating.Additional information has been requested.
Additional Manufacturer Narrative
Updated fields: d4 (serial# and udi), d9, g3, g6, h2, h3, h4, h6, h11.The cusa excel 23khz straight handpiece (c2600p) 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 returned handpiece (hp) verified customer complaint as valid.The transducer was found to be twisted in the handpiece housing because the torque base was not (or not correctly) used, which is a user mistake.The housing has a crack, the handpiece is giving a cooling alarm, and annual maintenance needs to be performed.To resolve the issue, the housing and all o-rings of the coil form have been replaced, and a full function test including calibration and safety test according to the manufacturer's guidelines has been performed.Root cause - the root cause is confirmed as "cracked housing and overheating." due to the handpiece being cracked it is no longer a sealed unit; air can enter the cooling system and trigger a cooling alarm.Due to the air in the system, the cooling water flow rate is reduced potentially resulting in insufficient cooling, causing the handpiece to heat up.Additionally, during the service it was noted that the handpiece had also been overtorqued.The issue of cracked housing is currently under investigation pending root cause and corrective action.However, there are no capas associated with "overheating." at present we consider this complaint to be closed.

• Brand Name: EXCEL 23KHZ STRAIGHT HANDPIECE C2600P
• Common Device Name: TISSUE ABLATION
• 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: 24329067
• Report Number: 3006697299-2026-00011
• Device Sequence Number: 15821660
• Product Code: LFL
• UDI-Device Identifier: 10381780039419
• UDI-Public: 10381780039419
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

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: C2600P
• 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: 01/23/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2021
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3006697299-05/29/2024-00
• Patient Sequence Number: 1
• Patient Sex: Unknown