MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. VERSAJET EXACT ASSY, 45 DEGREE X 14MM; LAVAGE, JET

Model Number	66800041
Medical Device Problem Code	No Pressure (2994)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during debridement of a wound the handpiece of a versajet exact assy, 45 degree x 14mm no longer provided pressure after intermittent use of one hour and thirty minutes.The procedure had a delay of 20 minutes, there was no backup available and was confirmed that it was not completed.Patient was not harmed as a consequence of this problem.
Additional Manufacturer Narrative
H3, h6.The device was not returned for evaluation.A documentation review was performed.Historical review has revealed no other cases from the reported product or lot number, there are no open nor closed escalation actions within scope.Manufacturing records detail no contributory factors, records reveal the device met the required specifications upon release into distribution.The associated risk files adequately mitigate loss of pressure during use, without further details regarding the sequence of events, or opportunity to evaluate the handpiece or associated console the probable cause remains unknown.The instruction for use details that the when the device detects an internal motor failure, which will impact on pressure, it will display a failure f2 directing the user to replace the console.No error message was displayed.Factors that may affect efficiency are detailed within the instruction for use, if the saline bag is allowed to run empty air will enter the system temporarily reducing efficiency.No manufacturing quality concerns have been observed, therefore no corrective actions are deemed necessary.
Additional Manufacturer Narrative
H11.Corrected information in h6 (health effect - impact code).

• Brand Name: VERSAJET EXACT ASSY, 45 DEGREE X 14MM
• 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: 15142793
• Report Number: 8043484-2022-00182
• Device Sequence Number: 12138573
• Product Code: FQH
• UDI-Device Identifier: 00040565124681
• UDI-Public: 00040565124681
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/06/2023

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: 66800041
• Device Catalogue Number: 66800041
• Device Lot Number: 50450595
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2022
• Supplement Date Received by Manufacturer: 02/14/2023; 07/06/2023
• Initial Report FDA Received Date: 08/01/2022
• Supplement Report FDA Received Date: 02/15/2023; 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 20 YR
• Patient Sex: Female