MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. VERSAJET II CONSOLE; CATHETER, DOUBLE LUMEN FEMALE URETHROGRAPHIC

Catalog Number	66800039
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that, during a debridement procedure, when changing the iv bag the versajet ii console blocked.The procedure was resumed, after a significant delay, by changing the surgical technique.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
Section h10: the device was returned for evaluation.A visual and functional evaluation was performed.No material defects was noted and the device passed all functional testing, no faults was found.A documentation review was performed.The manufacturing records and 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 release.A 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.A review of the product risk files, finds the combination of product, event type and associated harms are anticipated, with no updates required.With no faults found, the probable cause remains unknown, factors may include that during the changeover of saline, air entered the system, when this occurs full re-priming is needed.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).

• Brand Name: VERSAJET II CONSOLE
• Common Device Name: CATHETER, DOUBLE LUMEN FEMALE URETHROGRAPHIC
• 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: 18636450
• Report Number: 8043484-2024-00015
• Device Sequence Number: 15436359
• Product Code: FGH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2024

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: 01/09/2024
• Supplement Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 02/02/2024
• Supplement Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown