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

Catalog Number	C2602
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h11.The cusa excel 36khz straight handpiece (c2602) was returned for evaluation: device history record (dhr) review - the dhr documentation was reviewed and no anomalies during the manufacture or packaging that could be associated with the complaint incident was observed.Failure analysis - the investigation of the unit confirmed the complaint as valid: the handpiece is overheating; the transducer is faulty and the coilform pin is damaged.As a result, the transducer, coilform, housing and o-rings were replaced, and the device now meets manufacturer specifications.Root cause - the root cause is confirmed as "transducer function found to be outside of specifications; coilform pin is damaged.Both occurred after 12 years in the field." 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.
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 distributor reported that the cusa excel 36khz straight handpiece (c2602) was heating during a liver surgery and had no frequency.There was no patient injury and no delay in surgery.

• 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: 21323521
• Report Number: 3006697299-2025-00012
• Device Sequence Number: 8494478
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2025

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: 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: 01/15/2025
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2013
• 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