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

Catalog Number	C7300
Medical Device Problem Code	Inability to Irrigate (1337)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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
This report is linked to mfg report number 3006697299-2024-00144 and 3006697299-2024-00152, and is for the 2nd surgery: after receiving additional information on mfg report# 3006697299-2024-00144 regarding irrigation issues during surgery involving c7300 cusa clarity quick connect tubing (c7300) indicating that the device only worked sequentially when irrigation was set to a maximum speed of 20 ml/min), the customer explained that this type of issue which increased the duration of surgery by more than 30 minutes continued to happen again and occurred during 3 surgical procedures in total.
Additional Manufacturer Narrative
The c7300 cusa clarity quick connect tubing (c7300) was not returned for evaluation, and a device history record (dhr) review was not possible because the lot number is unknown; therefore, a definite root cause determination is not possible.Failure analysis - the customer reported that the ¿irrigation only worked sequentially when irrigation was set at max speed 20 ml/min.¿ it is assumed that there is some sort of anomaly involving the equipment¿s irrigating function; however, it is not clearly understood what is meant by ¿irrigation only worked sequentially." as per the customer¿s internal evaluation/troubleshooting, the problem appears to have been isolated to the tubing component.However, based on the information provided the following may be concluded: the customer reports to be having a situation with cusa clarity tubing and that ¿changing of tubing has worked both times.¿ it seems that they only get flow if the irrigation is set at max speed of 20 ml/min.Potential root cause - as previously stated, a definite root cause cannot be determined without evaluating the unit involved in the reported event.There is a possibility of a faulty tubing set such as a blocked fitting or tube pinched inside the tubing cartridge which would cause irrigation issues.However, based on the above explanation where recurring events involving different lots are experienced at the same customer site could also indicate an internal non-identified issue such as equipment assembly errors.In the information provided it is mentioned that the tubing was exchanged for a different one and that this action corrected the problem; however, there is no mention of removing and reassembling the same unit to troubleshoot if the situation could be related to an incorrect tubing/cartridge assembly.Another possible cause could be that the sliding clamp was inadvertently left in the closed position not allowing irrigation solution to flow through the system.An awareness training addressing the possibility of a pinched irrigation-tube inside the cartridge was recently provided in august 2024.If the device is later returned, the complaint will be reopened to perform the respective evaluation and document the failure analysis.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• 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 08540 ; 6099362319
• MDR Report Key: 20362925
• Report Number: 3006697299-2024-00151
• Device Sequence Number: 12757302
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2024

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: C7300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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