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

Catalog Number	66800041
Medical Device Problem Codes	Partial Blockage (1065); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during treatment, the versajet exact assy, 45 degree x 14mm wouldn't absorb water back into it, won't cut tissue and the malfunction light was on.There was a significant delay and the procedure was finished using a smith & nephew back up, with a modified technique.Patient was not harmed.
Additional Manufacturer Narrative
Internal reference number case (b)(4).
Additional Manufacturer Narrative
H10: h3, h6: the device was not returned for evaluation.A review of the complaint history has revealed several similar cases, there are no open or closed escalation actions for this combination of product and failure modes.A review of the device history record showed that this unit passed all acceptance criteria and was compliant upon release for distribution.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 failures and associated harm has been anticipated.These failures are anticipated and is considered as acceptable.The probable cause remains unknown, factors include, poor fluid flow (including priming failures, airlock, and debris build-up), leading to loss of performance.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: 17557326
• Report Number: 8043484-2023-00055
• Device Sequence Number: 17404687
• Product Code: FQH
• UDI-Device Identifier: 00040565124681
• UDI-Public: 00040565124681
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2024

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
• Device Expiration Date: 10/26/2024
• Device Catalogue Number: 66800041
• Device Lot Number: 51077686
• 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: 08/03/2023
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown