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

Model Number 66800041

Device Problem Decrease in Pressure (1490)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/04/2023

Event Type  malfunction  

Manufacturer Narrative

Internal reference number: (b)(4).

Event Description

It was reported that, during procedure for a burn debridement procedure with versajet, the water came out at the back of a versajet ii exact 45dx14 mm, and no water was coming out from its end as intended, so it could not be used to cut.It was confirm that the device was correctly installed.As no problem was found, a second versajet ii exact 45dx14 mm was used, but it had the same issue.The procedure was performed, after significant delay, with a third s+n handpiece.It was conformed that patient was already anesthetized during the +30min delay.

Manufacturer Narrative

H6: the device was not returned for evaluation, therefore an assessment could not be performed.A documentation review was performed.Manufacturing records and processes.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.Complaint history and escalation actions.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, find the combination or product, event type and associated harms are anticipated, with no updates required.The probable cause remains unknown, factors may include an internal component failure.No manufacturing, packaging, labelling, design, concerns nor adverse trend have been observed, therefore no corrective actions are deemed necessary.

• Brand Name: VERSAJET EXACT ASSY, 45 DEGREE X 14MM
• Type of Device: 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: 17319365
• MDR Text Key: 319669363
• Report Number: 8043484-2023-00048
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00040565124681
• UDI-Public: 00040565124681
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K143115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 66800041
• Device Catalogue Number: 66800041
• Device Lot Number: 51064612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1