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

Catalog Number	C2600
Medical Device Problem Code	Misassembled During Installation (4049)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2024
Type of Reportable Event	Malfunction
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: due to incorrect use of the key holder, the sound transmitter was twisted when attaching the tip to the housing and the housing was broken.This is due to user error, (key holder was not used).As a result, the sound transmitter has been damaged, and the function is at the end of the specified specification and required to be replaced along with the housing and the associated sealing rings.In resolution, the sound transmitter, the housing and all o-rings were replaced.After repair, the handpiece was calibrated, inspected, and tested for safety in accordance with applicable manufacturer guidelines.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 corrective and preventative action (capa) has been raised to investigate this issue and is pending corrective action.
Event or Problem Description
A facility reported that the cusa excel 23khz straight handpiece (c2600) cannot be connected as the tip was twisted (overtorqued).Additional information was subsequently received indicating the following: the internal cooling water system of a concomitant device used (cusaexcel9) probably has a leak, which led to water escaping at the point of contact with the handpiece cable.The defect was detected intraoperatively before the handpiece was used.The surgery then had to be continued with ultracision, and the surgical time was greatly extended as a result.No adverse patient impact has been reported.

• Brand Name: CUSA EXCEL 23KHZ STRAIGHT HANDPIECE
• 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: 20291608
• Report Number: 3006697299-2024-00143
• Device Sequence Number: 7284204
• 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,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/24/2024

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
• Date Returned to Manufacturer: 05/16/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CUSA EXCEL W/ CONSOLE 220V AC WITH FOOTSWITCH.
• Patient Sex: Unknown