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

Catalog Number	C2602
Medical Device Problem Codes	Failure to Deliver Energy (1211); Output below Specifications (3004)
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 36khz straight handpiece (c2602) was in use for about 6 hours during surgery (= handpiece warm-up aspect) and it worked normally.After this time, problems appeared: the handpiece warmed up, lost power, the amplitude dropped, tissue fragmentation stopped.There was significant increased surgery due to product problem.
Additional Manufacturer Narrative
Updated fields: g3, g6, h2, h3, h11.Additional information received: name of healthcare facility: (b)(6).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The cusa excel 36khz straight handpiece (c2602) 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 evaluation verified customer information as valid: the coil form has water inside und the coil form must be dried and traces of water removed.The cable wire is broken on the coil form side and must be re-soldered, and the housing and all o-rings must be replaced.To resolve the issues, the coil form has been dried, broken wires on the coil from the side have been resoldered, and the housing and all o-rings have been replaced.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 failure of the coilform due to wire broken and coilform water ingress.No further investigation is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: g3, g6, h2, h6 (investigation findings and conclusion codes), h11 (root cause).Updated root cause - the root cause is confirmed as failure of the coilform due to wire broken and coilform water ingress.The fault may be due to wear and tear in the field.The device was manufactured in 2017 with this complaint being the device's first service.Annual preventative maintenance can help prevent the issues that occurred with this device.As water was present inside the coil form this can be avoided through regular maintenance where the coil form o-rings are changed ensuring the device is properly sealed.No further action is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

• Brand Name: CUSA EXCEL 36KHZ STRAIGHT HANDPIECE
• 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: 22555815
• Report Number: 3006697299-2025-00087
• Device Sequence Number: 15873534
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/27/2025

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
• 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: 06/26/2025
• Supplement Date Received by Manufacturer: 07/28/2025; 08/26/2025; 10/08/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 08/22/2025; 09/16/2025; 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2017
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown