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

Model Number	66800041
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference number (b)(4).
Event or Problem Description
It was reported that during surgery (re-debridement of full thickness burns on the left leg), after an hour of use, the versajet exact assy, 45 degree x 14mm began to spray lots of water.The procedure couldn´t be completed and the patient required re-debridements more than once, so it didn¿t affect the patient¿s care in the long run.It is unknown the current status of the patient.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation, therefore no evaluation has been performed.Documentation review.A review of the complaint history from date of manufacture for this product, has revealed a number of similar cases, no adverse trend or insight regarding the event has been observed.A review of escalation actions has revealed no open or closed actions within the scope of this case.A review of the device history record showed that this unit passed all acceptance criteria and was compliant upon release for distribution in.There were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.The risk management documentation for versajet has been reviewed to assess whether the alleged failure and associated harm has been anticipated.The event is anticipated within the risk files with no updates required.The probable cause remains unknown, factors may include a blocked evacuation orifice.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
• 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: 17159481
• Report Number: 8043484-2023-00039
• Device Sequence Number: 20599433
• Product Code: FQH
• UDI-Device Identifier: 00040565124681
• UDI-Public: 00040565124681
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K143115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2024

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
• Device Expiration Date: 09/29/2024
• Device Model Number: 66800041
• Device Catalogue Number: 66800041
• Device Lot Number: 51070506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2023
• Supplement Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown