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

Catalog Number	C2600P
Medical Device Problem Code	Crack (1135)
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 cusa excel 23khz straight handpiece (c2600p) was broken.The issue was observed during an unspecified procedure.There was prolongation of the surgical procedure exceeding 30 minutes; however, there was no patient injury and no smoke or burns occurred.Additional information has been requested.
Additional Manufacturer Narrative
Updated fields: d4, 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 returned handpiece (hp) was noted to be overtorqued during disassembly of the tip.This misuse caused the crack in the housing because the torque base was not (or not correctly) used.To resolve the issue, the housing and all o-rings of the coil form have been replaced.This (one time) housing replacement is per the terms of the current field safety notice (fsca) launched in may 2024.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 "incorrect assembly and disassembly of the handpiece by the customer using the torque wrench resulting in torque wrench misaligning the dot on the handpiece and the handpiece connector." regarding the issue of cracked housing, "fsca 3006697299-05/29/2024-001-c" was launched in may 2024.Additionally, a capa has been raised to investigate overtorquing of the hp and is pending corrective action implementation.However, investigations completed as part of both capas confirm there is no evidence to support a relationship between hp overtorquing and cracked housing.At present we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: EXCEL 23KHZ STRAIGHT HANDPIECE
• Common Device Name: ULTRASONIC SURGICAL PRODUCTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES (IRELAND) LTD.; sragh tullamore, co. offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES (IRELAND) LTD.; sragh tullamore, co. offaly ; EI
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 22806212
• Report Number: 3006697299-2025-00098
• Device Sequence Number: 8846530
• 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: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2025

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: C2600P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2017
• 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
• 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