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

Model Number	66800039
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during debridement versajet ii console vibrates, makes noise, and does not work.Treatment was resumed, after a significant delay, with a change in the technique.The patient was not harmed as a consequence of this problem.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the device was returned for evaluation.Visual inspection noted no issues.Functional evaluation found that the device operated as intended with no faults found.Reported noise or vibration was not replicated in testing or during device servicing, so no probable cause can be determined.A documentation review was performed.Manufacturing records.A review of device manufacturing records found no abnormalities were reported on this device during manufacture that would have contributed to the reported event.The relevant risk files pertaining to this device have been reviewed and contains details relating to abnormal mechanical noise and decreased performance.The risk has been anticipated and adequately mitigated, with a revision of the risk file not required.Historical data analysis a review of previous complaints found other complaints relating to vibration or noise produced by a versajet console.There are no previous escalations raised in relation to versajet consoles being reported to vibrate or make noise during operation.No manufacturing, design or labelling deficiencies have been confirmed to have contributed to this failure mode in other complaints.Factors that may have contributed to the reported failure may be that console required general servicing, or that the saline supply was left to empty, allowing air into the fluid line.This would inhibit the consoles ability to provide flow of saline, exerting stress on the pump, causing vibration/noise.The device instructions for use highlights the importance of ensuring this does not occur, as air in the supply tube can lower device efficiency and would require re-priming.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.Corrected data: d9, h3 (device was returned to manufacturer), h6 (health effect - impact code), h8.

• 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: 15882845
• Report Number: 8043484-2022-00203
• Device Sequence Number: 4939365
• Product Code: FQH
• UDI-Device Identifier: 00040565124759
• UDI-Public: 00040565124759
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2023

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2022
• Supplement Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2020
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown