MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) EXCEL 23KHZ STRAIGHT HANDPIECE EACH1; ULTRASONIC SURGICAL PRODUCTS

Catalog Number	C2600
Medical Device Problem Codes	Crack (1135); Inability to Irrigate (1337); 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 the cusa excel 23khz straight handpiece (c2600) was cracked, emitted a cooling water alarm and heated during operation.There was surgical delay of less than 30 minutes.Additional information has been requested.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h4, h6, h11.The cusa excel 23khz straight handpiece (c2600) 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 confirmed the complaint: the handpiece was over torqued, and this misuse caused the crack in the housing.The torque base was not (or not correctly) used, which is a user mistake.The coil form is faulty and has to be replaced, and the housing and all o-rings of the coil form need to be exchanged.This (one time) housing replacement will be covered under the terms of the field safety notice.A full function test including calibration and safety test according to the manufacturer guidelines has been performed.Root causes - the root causes are confirmed as: handpiece overtorquing, cracked housing and cooling alarm: 1) the overtorquing of the handpiece is due to incorrect assembly and disassembly of the handpiece by the customer using the torque wrench.This resulted in the torque wrench misaligning the dot on the handpiece and the handpiece connector.2) root causes of cracking failures on c2600 are due to: a.Poor blending of the filler fibres b.Tool design and/or moulding process parameters allowing voids & defects 3) root cause of cooling water alarm and heating ae as a result of the twisting motion during overtorquing - the cooling tubes may have become twisted, curtailing the cooling water flow causing the handpiece tip to heat.Note that there is no confirmed relationship between over torquing and cracked housings.However, a capas' have been raised to investigate the reported issues and are pending corrective action.At present, we consider this complaint to be closed.

• Brand Name: EXCEL 23KHZ 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: 22185325
• Report Number: 3006697299-2025-00067
• Device Sequence Number: 8617040
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• 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: C2600
• 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: 05/20/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2022
• 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