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

Model Number	C3601
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2022
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 the cusa excel 36khz tubing set (c3601) was used in a tumorectomy procedure, and when the tube was attached to the main unit and primed, water leakage occurred near the irrigation pump before the procedure.Two cracks were confirmed in the product.Therefore, another product was used to complete the procedure.No surgical delay and adverse consequences to the patient were observed.
Additional Manufacturer Narrative
Cusa excel 36khz tubing set (c3601) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Additional Manufacturer Narrative
The cusa excel 36khz tubing set (c3601) was returned for evaluation: failure analysis : the returned tube was tested for leakage condition by introducing water through the irrigation tube with a syringe.A leakage was observed in the irrigation tube (with blue strip).In addition, some scuff marks were observed in the area of the irrigation tube where the leak was observed.The damage observed in this section of the irrigation tube is consistent with the defect cause when the tube is incorrectly assembled into the pump latch, and it is pinched under compression.The reported condition of ¿leakage¿ was confirmed.Root cause : based on the unit evaluation, the root cause of the reported condition is related to an improper assembly of the tube into the console machine.The complaint investigation rules out any relationship of the reported condition with the product manufacturing process at integra.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.The cusa excel user¿s guide provides the proper instructions for the tubing assembly into the console machine and has the following caution statement to avoid damages to the tube: ¿make sure that the irrigation tubing center between the v-shaped tubing retainers before you close the pump latch.Otherwise, the pump latch will pinch the tubing, preventing the flow of irrigation fluid.¿.

• 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: 15728723
• Report Number: 3006697299-2022-00152
• Device Sequence Number: 14171298
• Product Code: LFL
• UDI-Device Identifier: 30381780025867
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/03/2023

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 Model Number: C3601
• Device Catalogue Number: C3601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2022
• Supplement Date Received by Manufacturer: 11/14/2022; 01/26/2023
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 12/13/2022; 02/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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