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

Model Number	66800039
Medical Device Problem Codes	Loss of Power (1475); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during debridement, when the pedal is pressed no jet comes out of the handpiece.The versajet ii console makes an abnormal noise and then, as soon as the foot is removed from the pedal, a jet of saline is made and it turns off.It was tested with another handpiece and did the same.The procedure was cancelled.No harm to the patient reported.
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).
Additional Manufacturer Narrative
D4 was updated (serial #).
Additional Manufacturer Narrative
H10: no device has been made available for evaluation, the event is not confirmed or related to a device malfunction or manufacturing concern.A documentation review has revealed no previous instances and there are no open corrective actions.The manufacturing records have revealed no contributory factors, the device met the required specifications on release into distribution.The risk files mitigate the event type reported which is further delineated in the instruction for use "ifu", which provides the probable cause.The ifu further warns that the when priming saline to ensure that there are no kink of blockages within the system, this includes air blockages, this can occur if the saline supply is interrupted.The ifu further warns to ensure that the console is fully primed and operation prior to the commencement of anesthesia.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.Internal complaint reference number: case-(b)(4).

• 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: 13794534
• Report Number: 8043484-2022-00104
• Device Sequence Number: 11769705
• Product Code: FQH
• UDI-Device Identifier: 00040565124759
• UDI-Public: 00040565124759
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K143115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 66800039
• Device Catalogue Number: 66800039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2022
• Supplement Date Received by Manufacturer: 02/25/2022; 07/12/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 05/26/2022; 08/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown