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

Catalog Number	C2600
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
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 during surgery, the excel 23khz straight handpiece each1 (c2600) heats up after 1 minute.No patient injury has been reported.There was no significant surgical delay.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The excel 23khz straight handpiece each1 (c2600) 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 - the evaluation verified the customer reported issue as valid.The cooling tubing inside the connector has to be re-glued, and the calibration, safety and the final test according to the manufacturer's specification must be performed.Root cause - the complaint is confirmed and the root cause is confirmed as wear and tear of the cooling tubing.The cooling tube inside the connector has to be re-glued after approximately five years in the field.No relevant capas were discovered no other actions have been identified relating to this issue, and no manufacturing, workmanship, or material deficiency was identified for correction because of this complaint investigation.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• 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: 23510039
• Report Number: 3006697299-2025-00126
• Device Sequence Number: 9742190
• 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: Company Representative,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2025

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: 10/13/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2020
• 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