MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA CLARITY 23 KHZ EXTENDED LENGTH LAPAROSCOPIC TIP PACK (5 PACK)

Catalog Number	C7404LS
Medical Device Problem Code	Failure to Prime (1492)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that during a surgical procedure the fluid would not prime all the way through to the cusa clarity 23 khz extended length laparoscopic tip (c7404ls), causing pressure to build up and the pump to make a ratcheting noise.Additional information was reported as follows: 1.Was there a delay in surgery due to product problem? if yes, how long? this causes a delay to the surgery.I was only present for the first portion of the delay which was 45 minutes.I'm not sure how much longer the delay was once i left.2.Please advise what the total amount of surgical delay for this case was in minutes/hours.I don¿t know and was not able to get additional answers from the hospital.3.Was the patient under anesthesia when the malfunction occurred? yes.
Additional Manufacturer Narrative
Cusa clarity 23 khz extended length laparoscopic tip (c7404ls) was returned for evaluation: device history record (dhr) - the dhr was reviewed, and no anomalies were found that could contribute and/or be related to the reported condition.Failure analysis - the investigation of the unit confirmed that the returned tip is clogged.Root cause - the root cause is most likely that matter got stuck inside the device during use.No further investigation is required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

• Brand Name: CUSA CLARITY 23 KHZ EXTENDED LENGTH LAPAROSCOPIC TIP PACK (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: 20698360
• Report Number: 3006697299-2024-00165
• Device Sequence Number: 6489396
• Product Code: LFL
• UDI-Device Identifier: 10381780533894
• UDI-Public: 10381780533894
• Combination Product (Y/N): N
• PMA/510(K) Number: K221763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/15/2024

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 Expiration Date: 08/31/2026
• Device Catalogue Number: C7404LS
• Device Lot Number: 7282219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2023
• 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