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

Catalog Number	C2600
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2024
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
An authorized distributor reported that the cusa excel 23khz straight handpiece (c2600) emitted a vibration alert during a case.There was no impact to the patient, but increased surgery time of longer than 30 minutes was reported.Final user: (b)(6) hospital.
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 evaluation of the unit confirmed the complaint: several cable wires are broken where they were soldered to the coliform and need to be re-soldered.This was the cause of the vibration alarm.The housing and all o-rings of the coil form need to be exchanged.The calibration and the final test according to the manufacturer's specification must be performed.Root cause: the likely root cause is wear and tear after 5 years in the field, and also there may have been stress on the solder joint when housing was replaced in 2022.No further investigation is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.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: 19279376
• Report Number: 3006697299-2024-00056
• Device Sequence Number: 6336182
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2019
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown