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

Model Number	66800039
Medical Device Problem Codes	Connection Problem (2900); Noise, Audible (3273)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during an arthroscopy, the versajet ii console does not do its function, and makes a lot of noise when used with a 8-position connection, and according to the customer, it does not work with the 14-position connection.The procedure was cancelled.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Internal complaint reference number:(b)(4) section b5 was corrected.
Event or Problem Description
It was reported that, during a wound debridement treatment, the versajet ii console does not work: it makes a lot of noise when used with a 8 mm handpiece, and it does not work with the 14 mm.The procedure was cancelled.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
Section h10: the device was returned for evaluation.A visual and functional assessment was performed.No material nor functional failures was observed, the device passed all testing.A documentation review was performed.The manufacturing records and inspection processes for the reported batch contain no contributory factors, records confirm that this batch was manufactured, meeting the required specifications.All inspection and testing requirement was met prior to the release.Historical review details previous cases of this nature, which are considered isolated in scope and there are no open nor closed escalation actions related to this event type.The risk management files adequately captures both of the reported concerns, with no updates required.The probable cause remains unknown.Factors may include a defect with the actual handpiece used, but that component has not bee returned for evaluation to support this case.No manufacturing, packaging, labelling, design, concerns nor adverse trend have been observed, therefore no corrective actions are deemed necessary.Internal complaint reference number: (b)(4).
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4) section h6 (health effect - clinical code and health effect - impact code) was corrected.

• 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: 16678573
• Report Number: 8043484-2023-00024
• Device Sequence Number: 5435439
• Product Code: FQH
• UDI-Device Identifier: 00040565124759
• UDI-Public: 00040565124759
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/01/2024

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 Model Number: 66800039
• Device Catalogue Number: 66800039
• 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: 03/14/2023
• Supplement Date Received by Manufacturer: 06/23/2023; 06/23/2023; 09/25/2024
• Initial Report FDA Received Date: 04/04/2023
• Supplement Report FDA Received Date: 06/26/2023; 06/27/2023; 10/01/2024
• 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