MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LTD. EXCEL 36KHZ STRAIGHT HANDPIECE EACH1; ULTRASONIC SURGICAL PRODUCTS

Catalog Number	C2602
Medical Device Problem Code	Misassembled During Installation (4049)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
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
This report is 3 of 3 for the 3rd handpiece used in the case and is linked to mfg report numbers 3006697299-2025-00028 and 3006697299-2025-00031: a defect occurred during surgery: the cusa excel had a cooling water alarm: the handpiece (hp) (et4662, pr (b)(4)) (tip) was installed correctly.While testing the hp, the amplitude light only rose to 10% instead of the 100%, so giving hp alarm.When testing the hp again, then it gave cooling water alarm.A second cusa hp (b)(6) (pr (b)(4)) was used and worked 1 or 2 times and went back in cooling water alarm many times.The surgery team continued surgery with the cusa excel after each use (of 30 seconds (+/-?)) shut down cusa and starting it up again.The surgery was extended for more than 30 minutes.The third hp (b)(6) (pr (b)(4)) was tested also during the surgery but didn't work.(the sales rep said that it was overtorqued).The surgical outcome was ok.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The excel 36khz straight handpiece (c2602) 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 incident was observed.Failure analysis - the investigation of the unit confirms that the handpiece (hp) failed and is overtorqued.Root cause - the root cause is confirmed as overtorquing due to incorrect assembly and disassembly of the hp by the customer using the torque wrench.This resulted in the torque wrench misaligning the dot on the hp and the hp connector.A corrective and preventative action (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.

• Brand Name: EXCEL 36KHZ STRAIGHT HANDPIECE EACH1
• Common Device Name: ULTRASONIC SURGICAL PRODUCTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES (IRELAND) LTD.; sragh tullamore, co. offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES (IRELAND) LTD.; sragh tullamore, co. offaly ; EI
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 21599751
• Report Number: 3006697299-2025-00030
• Device Sequence Number: 12844750
• 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): 05/29/2025

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: 02/18/2025
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2018
• 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