MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA CLARITY QUICK CONNECT TUBING SET (5 PACK)

Model Number	C7300
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that prior to a liver resection procedure, the cusa clarity quick connect tubing set (c7300) irrigation tube was misaligned.Surgical time was extended more than 30 minutes.The device was changed to a new one and the procedure was successfully completed.
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.
Additional Manufacturer Narrative
The cusa clarity quick connect tubing set (5 pack) (c7300) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Device history record (dhr) - lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.Failure analysis - documentation review of the reported lot did not reveal any anomalies associated to the manufacturing process of the product which could contribute and/or be related to the reported condition.No unit has been received for evaluation; however, a photo was provided, and the reported condition was confirmed.Root cause - the root cause for this complaint is related to an operator oversight when assembling/inspecting the cassette assembly.As per local procedure, once the cassette is assembled, the operator must verify that the cassette has been closed properly (no open borders, no pinched tubing, no cassette damages).Corrective action - an awareness training was provided to all cusa section personnel to inform about the complaint findings, show the photo of the reported condition and discuss procedural controls; also, stressed on the importance of product inspection to ensure that the product has no defects.No other action is deemed necessary at this moment since procedural controls are in place.Future incidents (if any) of this nature will be documented for recurrence and trending purposes.

• Brand Name: CUSA CLARITY QUICK CONNECT TUBING SET (5 PACK)
• Common Device Name: CUSA CLARITY
• 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: 16211395
• Report Number: 3006697299-2023-00003
• Device Sequence Number: 5383251
• Product Code: LFL
• UDI-Device Identifier: 10381780126287
• UDI-Public: 10381780126287
• Combination Product (Y/N): N
• PMA/510(K) Number: K161882
• 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
• 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 Expiration Date: 04/30/2025
• Device Model Number: C7300
• Device Catalogue Number: C7300
• Device Lot Number: 6297671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/28/2022
• Supplement Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 02/04/2023
• Date Device Manufactured: 04/19/2022
• 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