MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD SUCT/IRRIG CANNULA SET (10/5); LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	600340
Medical Device Problem Code	Leak/Splash (1354)
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
It was reported that once irrigation was engaged, the suct/irrig cannula set (600340) continued to drip from the cannula.The product was not used in surgery but was tested and found to have leaked.
Additional Manufacturer Narrative
Updates fields: d4 (udi#), d4 (lot#).Corrected field: d4 (serial number).Two suction/irrigation cannula set (10/5) (600340) were returned for evaluation.The device history record (dhr) was reviewed, and no anomalies related to the reported issue were identified.Failure analysis - visual and functional evaluation were performed.The returned cannulas were in used condition with the irrigation valves stuck in place.The valves could not be disassembled by hand.When water was pumped through the irrigation valve, there was no leakage out of the end of the tubes.Supplier evaluation was performed and identified that the shape of the trumpet valve may allow leakage due to a gap between the shaft and the sleeve.No additional risk was identified from leakage and the supplier stated that leakage is an expected outcome.Lubrication of the valves can help to create a stronger seal.Per the instructions for use (ifu), "the use of an instrument lubricant, that is compatible with the method of sterilization to be used, is recommended before instruments are sterilized.Note that ultrasonic cleaners remove all lubrication; therefore this maintenance procedure should be done routinely after ultrasonic cleaning and before sterilization." root cause - the reported complaint was confirmed.It was determined that the irrigation valve buttons were stuck and unable to function due to rough handling or removal of parts.Water leakage is an expected result of use of the device.No manufacturing, workmanship or material deficiency has been identified.
Event or Problem Description
N/a.

• Brand Name: SUCT/IRRIG CANNULA SET (10/5)
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 19244251
• Report Number: 3014334038-2024-00095
• Device Sequence Number: 17884540
• Product Code: GCJ
• UDI-Device Identifier: 10381780156895
• UDI-Public: 10381780156895
• Combination Product (Y/N): N
• PMA/510(K) Number: K060233
• 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): 09/24/2024

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: Other
• Device Catalogue Number: 600340
• Device Lot Number: BK2310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• 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