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)
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that heat builds up on the excel 23khz straight handpiece (c2600).There was no patient/user injury or significant surgical delay.
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
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 - investigation of the returned device shows that axial misalignment has occurred due to over torque during chip installation.As a result of the axial misalignment, the vibrator started rotating and got caught in the housing (the resin part of the handle), which caused the vibrator to not vibrate normally.Additionally, due to the rotation of the vibrator, the interior of the housing was worn down, and fragments of the damaged housing flowed into the irrigation flow path inside the cable, which likely caused a decrease in the irrigation flow rate and resulted in heat generation.However, the irrigation system for the handpiece is a closed system and does not come into contact with the patient.To resolve the issues, the damaged housing, the cable that has fragments, and the coil form will be replaced as there is a wire break inside.Root cause - the root causes are confirmed as: 1) overtorquing 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 hp and the hp connector.A capa has been raised to investigate if output from technical note for ¿hp overtorqing¿ ensured that the information was updated and distributed to all relevant parties, for example post operative intervention for purposes of removing tip and cleaning.2) coilform failure due to wire broken after 5 years in the field.This is a single complaint occurrence with no adverse trend observed.3) fragments of the damaged housing flowed into the irrigation cooling tube, which may have caused a blockage and therefore caused a decrease in the irrigation flow rate and resulted in heat generation.However , this is a closed system and does not come into contact with the patient.Trends will be monitored for this and similar issues.
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: 21602010
• Report Number: 3006697299-2025-00029
• Device Sequence Number: 4431206
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

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: 02/18/2025
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 05/22/2025
• 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