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

Catalog Number	C2600
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
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 when using the cusa excel generator with the cusa excel 23khz straight handpiece, an error message was displayed: "leak at the circuit level." after inspection of the handpiece, a crack in the junction between the needle thread and the handle was found, making it impossible to use.They needed to replace the handpiece with longer intervention time, and the next operation was to take place under laparoscopy but no laparoscopy handpieces were available (stock of 2 handpieces in the operating room).The operation had to be transformed into a laparotomy.
Additional Manufacturer Narrative
Updated fields: g3, g6, h2, h11.Additional information received indicating the following: the increase of the surgery time was less than 30 minutes.Customer does not have the identity of the patient regarding this incident to share.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The cusa excel 23khz straight handpiece (c2600) was returned for evaluation: device history record (dhr) ¿ the dhr was reviewed and no anomalies that could be associated with the complaint incident was observed.Failure analysis - the investigation of the unit confirmed the complaint: the handpiece is overtorqued as a result of misuse that caused a crack in the housing.The torque base was not (or not correctly) used which is user mistake.To resolve the issues, the housing and the associated o-rings have been replaced, and the calibration, safety and final test according to manufacturer guidelines have been performed.Root cause - the root cause is confirmed as 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 handpiece and the handpiece connector.A capa has been raised to investigate overtorquing of the handpiece and is pending corrective action.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: CUSA EXCEL 23KHZ STRAIGHT HANDPIECE
• 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: 21074618
• Report Number: 3006697299-2024-00187
• Device Sequence Number: 20526537
• 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: Foreign,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/07/2025

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 01/14/2025; 02/27/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 02/06/2025; 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2017
• 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 -05/29/2024-0
• Patient Sequence Number: 1
• Patient Sex: Unknown