MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. VERSAJET II CONSOLE; LAVAGE, JET

Model Number	66800039
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference number (b)(4).
Event or Problem Description
It was reported that after insert versajet ii exact to the versajet ii console, it cannot turn the pump cartridge clockwise.The procedure was performed, after significant delay, with a change in the treatment.The patient was under anesthesia during such delay.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
H3, h6: the device was returned for evaluation.A visual inspection of device found no issues.A functional evaluation found that a test handpiece could not be turned to the locked position within the user interface assembly due to corrosion in the interlock.A review of the manufacturing records of this device offers no insight into the cause of the reported event.The device was manufactured and released according to all relevant specifications and testing.A historical review of previous complaints and escalations found a number of similar complaints reporting this failure mode, with this being the first report made against this console.Previous corrective actions have determined that the root cause is a result of corrosion within the interlock assembly, caused by a build up of salt deposits from saline solution within the user interface.Actions implemented include a change to the handpiece instructions for use, advising that the user inspects and clean the interlock with a damp cloth to avoid degradation over time.It is also advised to ensure the saline supply does not run dry during debridement, as frequent re-priming involving insertion and removal of handpieces allows for saline spillage and ingress into user interface.A review of the relevant risk files in relation to this failure mode found that all risks relating to handpiece failing to connect are deemed low risk to the patient.The risks are anticipated and adequately mitigated with no changes required at this time.Cause of the reported fitting problem with the handpiece determined to be corrosion within the interlock in the user interface assembly.No manufacturing quality concerns have been observed, therefore no corrective actions are deemed necessary, smith and nephew will continue to monitor for adverse trends relating to the reported allegation.Additional information: b1, d5, d7a, d8, d9, h8.Corrected data: g2, h6 (health effect - impact code).

• Brand Name: VERSAJET II CONSOLE
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 17159584
• Report Number: 8043484-2023-00041
• Device Sequence Number: 5590283
• Product Code: FQH
• UDI-Device Identifier: 00040565124759
• UDI-Public: 00040565124759
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K143115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2023

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: 66800039
• Device Catalogue Number: 66800039
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2023
• Supplement Date Received by Manufacturer: 12/28/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 12/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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