MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LTD. 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	08/02/2024
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 during an operation in which the cusa excel 23khz straight handpiece (c2600) and the "cusa excel w/ console 220v ac with footswitch was used, the monitor went to flush alarm.This issue extended the surgery time for approximately 30 minutes, and the surgery was completed with a second replacement device.According to the technical service team, they did not check the console with another handpiece.
Additional Manufacturer Narrative
The cusa excel 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 as valid: the handpiece was overtightened, and the over-tightening is due to incorrect use, which caused the housing to crack.Therefore, this is considered a user error as the key holder was not used.Additionally, a cable on the transformer coil side was broken off and needs to be re-soldered, and the housing and the associated sealing rings must be replaced.To resolve the issues, three cable lines on the coil side were re-soldered and 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 was confirmed as "incorrect assembly and disassembly of the handpiece by the customer using the torque wrench resulting in torque wrench misaligning the dot on the handpiece and the handpiece connector." regarding the issue of cracked housing, the housing was replaced under "fsca 3006697299-05/29/2024-001-c" which was launched in may 2024; therefore, no further action is required.At present we consider this complaint to be closed.

• 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: 20849304
• Report Number: 3006697299-2024-00173
• Device Sequence Number: 8039748
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2024

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2018
• 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
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CUSA EXCEL W/ CONSOLE 220V AC WITH FOOTSWITCH
• Patient Sex: Unknown