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

Model Number	66800039
Medical Device Problem Codes	Failure to Prime (1492); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during set up/ inspection, before a procedure, the versajet ii console turned on but when the pedal was pressed it did not purge the line.This led to a change in the surgical technique and a delay of less than or equal to 30 minutes.No patient harm reported.
Additional Manufacturer Narrative
H10: additional information.The reported versajet device was received for complaint evaluation, the concomitant handpiece and foot pedal was not returned.All supplied information has been reviewed and we have not been able to confirm the complaint or relate the reported event to a manufacturing problem.Visual and functional evaluation was performed, on the console with a test handpiece and footswitch with no faults found, the device primed the test handpiece as expected.Potential cause may include ensuring that the device and handpiece are set up in accordance with the instruction for use.A faulty foot pedal cannot be ruled out as a contributory factor.The instructions for use contain comprehensive instructions on the safe operation and use of the device.The risk files mitigate the reported issue with no updates required.A review of the manufacturing records found that there was no evidence that the products did not meet specifications at the time of manufacture.A complaint history review revealed further instances of this nature, as no manufacturing problems was observed, no corrective actions are deemed necessary this investigation is now complete.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

• 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: 12538153
• Report Number: 8043484-2021-01789
• Device Sequence Number: 11096564
• 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
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2022

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 Expiration Date: 02/25/2023
• Device Model Number: 66800039
• Device Catalogue Number: 66800041
• Device Lot Number: 50923900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2021
• Supplement Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN VERSAJET FOOTSWITCH; VERSAJET EXACT ASSY, 45 DEG X 14MM (PART 66800041)
• Patient Sex: Unknown