MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA EXCEL 36KHZ TUBING SET; ULTRASONIC SURGICAL PRODUCTS

Model Number	C3601
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
This is 4 of 4 reports linked to mfg report numbers: 3006697299-2022-00021, 3006697299-2022-00022, and 3006697299-2022-00023.A facility reported that the amplitude could not go up during fragmentation.They changed to a new tip and consumables.Cusa excel 36khz tubing set (c3601) device was involved, and surgical delay of 30-40 minutes was reported.There was no adverse patient consequence.
Additional Manufacturer Narrative
The cusa excel 36khz tubing set was not returned for evaluation as per customer, the device was blood contaminated; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.Also, as per product general troubleshooting guide, amplitude situations are related to excessive tip/tissue pressure (stalling tip), blocked tip, incorrect flue installed, tip loose due to improper assembly, console not left in run mode for a minimum of tow continuous minutes (36 khz handpiece only), damaged or cracked tip, and damaged handpiece.None of the previously mentioned possible root causes include the manifold tubing; therefore, it is understood that the event is unrelated to the cusa excel 36khz tubing set, catalog c3601.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: CUSA EXCEL 36KHZ TUBING SET
• 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 ; 6099362319
• MDR Report Key: 13599644
• Report Number: 3006697299-2022-00024
• Device Sequence Number: 13935727
• Product Code: LFL
• UDI-Device Identifier: 10381780025863
• UDI-Public: 10381780025863
• 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
• Report Date (Section B): 02/25/2022

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 Expiration Date: 03/31/2023
• Device Model Number: C3601
• Device Catalogue Number: C3601
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 02/25/2022
• Date Device Manufactured: 03/07/2020
• 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