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

Catalog Number	66800039
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during debridement, one (1) versajet ii console displayed a red alarm light and stopped working; it seemed to be blocked.The procedure was canceled, and it remains unknown if it will be completed later in time.The patient was not injured as a consequence of this problem.
Additional Manufacturer Narrative
Additional information: h3, h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the device was returned for evaluation.The visual inspection revealed no issues.A functional evaluation performed on the device revealed that the system fault indicator illuminates at start up.The user interface printed circuit board was defective.A review of the production order did not reveal a manufacturing abnormality that could cause or contributed to the reported incident.A review of complaint history revealed similar events for the listed device over the previous 14 months, but no other complaints with the same serial number, as this is a unique serial device, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode/adverse event was previously identified.The anticipated risk level is still adequate.A historical review concluded that no prior escalated actions related to this part number and failure mode.A factor that could contribute to the reported event include damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.We recommend that all reusable devices be routinely inspected for wear and damage and replaced as necessary.No manufacturing, packaging, labelling, design, concerns nor adverse trend have been observed; therefore, no corrective actions are deemed necessary.Corrected data: d9 (sample returned for analysis), h6 (health effect - impact code).

• 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: 19558951
• Report Number: 8043484-2024-00062
• Device Sequence Number: 4850687
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2024

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: 05/29/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 10/01/2024
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown