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

Catalog Number	66800039
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: case-2024-00215796-1.
Event or Problem Description
It was reported that, during debridement surgery, one (1) versajet ii console stopped suctioning.There were air bubbles no matter how much they changed the iv bag and tried to get the air out, it did not work.The procedure was resumed, after a significant delay, using a s+n backup device.No further complications were reported as a consequence of this issue.
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 task was performed, and it was found that the cover is scratched.Functional evaluation was performed, and the device works as intended with no technical errors detected.All tests are completed.A review of the associated serial record showed that this serial device passed all acceptance criteria and was compliant upon release for distribution.There were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A review of complaint history did not reveal similar events for the listed product for the timeframe.No other complaints with the same serial number, as this is a unique serial device.A review concluded that there are no prior escalated actions related to this part number and failure mode.The risk management documentation for versajet ii has been reviewed to assess whether the alleged failure and associated harm has been anticipated.There are multiple sequences of events related to saline flow issues.No harm occurred as a result of these issues.No defects were found on the returned device; therefore, no factors that can contribute to the reported event can be delineated.No manufacturing, packaging, labelling, design, concerns nor adverse trend have been observed; therefore, no corrective actions are deemed necessary.Corrected data: d9 & h3 (console returned for analysis).

• 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: 19812133
• Report Number: 8043484-2024-00070
• Device Sequence Number: 15550866
• 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
• Report Date (Section B): 09/18/2024

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 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: 07/02/2024
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 09/18/2024
• 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