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.
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Additional information: b2 (outcomes of adverse event), h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the console was returned for evaluation.A visual inspection of the device noted no issues.A functional evaluation found that the device motor was noisy on start up of the device, as well as that the system fault indicator illuminated on start up.No issues were noted in relation to the device being unable to accept a handpiece of any kind.Cause of the reported noise and system fault determined to be that the main motor in the device had become worn/defective and required replacement.Cause of the system fault determined to be that the user interface circuit board in the device was also defective and required replacement.Cause of the handpiece connection issues remains undetermined at this time, with factors unable to be provided as to why the user had issues connecting one type of handpiece but not others.Without lot numbers provided of the handpieces used in the procedure, these cannot be ruled out as a potential factor in the reported failure.A review of the device history was performed: a review of the console manufacturing records found that this device was produced and released according the approved specifications, with no non-conformances or deviations associated with this device, these records offer no insight into the cause of the reported failure.A review of previous complaints found other reports against both noise being generated during use, and against difficulty connecting handpieces to the console interface.No previous escalations or corrective actions have been implemented in relation to these failures.Device instructions for use contains adequate guidance on connecting versajet ii handpieces to the console, with the instructions remaining the same for any type of handpiece used.There should be no reason that one handpiece option is able to connect to the console while another will not.Instructions for use does not provide any information on what to do in the event of the console creating noise during use.However it does advise that if the console or a component is believed to be faulty, damaged, or suspect (which can be assumed from unexpected noise), then the device should not be used, with further instruction to contact local s+n representative.A review of the relevant risk files concluded that wear of internal serviceable components that leads to issues such as improperly fitting handpieces and noise is an expected failure of the console.Without a report of injury to the patient, this risk has been determined to be acceptable with no updates to the risk file required at this time.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 returned to manufacturer).
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