MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) EXCEL 36KHZ STRAIGHT HANDPIECE EACH1; 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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of our investigation, a follow-up report will be submitted.
Event or Problem Description
A facility returned the cusa excel 36khz straight handpiece each1 (c2602) which failed the incoming performance test with a stroke of 7.7mils and was also over-heating on 10 minutes test.There was no patient involvement or user injury.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The excel 36khz straight handpiece (b)(6) was returned for evaluation: device history record (dhr) - 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 - due to the overheating failure of the loaner handpiece, the transducer was replaced and fitted with the 8.45kohm resistor to calibrate the handpiece to specification.All service and repair checks and functional tests were successfully passed per manufacturer specifications.Root cause - the root cause is confirmed as transducer failure.No corrective action has been initiated for the same or similar issue.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

• Brand Name: EXCEL 36KHZ 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: 23061971
• Report Number: 3006697299-2025-00110
• Device Sequence Number: 9849990
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2025

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: 08/19/2025
• Supplement Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2016
• 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