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

Catalog Number	C2600
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that the cusa excel 23khz straight handpiece (c2600) failed on first use after set up, resulting in 30 minutes surgical delay due to the faulty device.The issue occurred when the patient was already anesthetized; however, there was no injury or harm to the patient.
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.
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 unit confirms the customer's complaint: the housing has a crack because it was twisted in the handpiece housing.The torque base was not (or not correctly) used, which is a user mistake the wire on coil form side was broken and needs to be resoldered.The housing and all o-rings must be replaced, and a full function test including calibration and safety test according to the manufacturer's guidelines must be performed.To resolve the issues, all wires on the coil form have been resoldered, the housing and all o-rings have been replaced, and a full function test including calibration and safety test according to the manufacturer's guidelines has been performed.Root causes - the root causes are confirmed as: handpiece overtorquing, broken coil form, and cracked housing: 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 cause of coil form is due to broken solder in the coil form, and 3) root cause of cracked housing is under investigation per corrective and preventative action (capa).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: g3, g6, h2.Corrected field: h11 (root cause only).See updated/corrected root cause below: root causes are confirmed as: 1) overtorquing - 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) coilform issue - which is due to broken solder in the coilform.3) cracked housing - this is due to poor blending of the filler fibres and molding process issues allowing voids & defects.Evidence shows that voids and areas of poor material mixing are present in the affected areas.

• 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: 22184881
• Report Number: 3006697299-2025-00068
• Device Sequence Number: 15595891
• 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,Followup
• Report Date (Section B): 09/15/2025

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: 05/16/2025
• Supplement Date Received by Manufacturer: 07/29/2025; 08/25/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 08/22/2025; 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2023
• 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