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

Model Number 66800041

Device Problem Fluid/Blood Leak (1250)

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

Event Date 04/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that water line for tissue debridement was spreading all around from the versajet exact assy, 45 degree x 14mm.It is unknown whether the event happened during surgery and if there was a patient involvement.

Manufacturer Narrative

H3, h6: the device was returned for evaluation, confirming the reported event.Visual inspection noted no obvious defects, an obstruction was observed under microscope.Functional evaluation confirmed the device could not prime.The root cause of the reported leak is determined to be caused by the obstruction found.The instructions for use, detail the pump interface should be inspected periodically for build-up of deposits and/or debris.A damp cloth with mild detergent can be used to remove material.A documentation investigation has been conducted, the device history confirmed that no manufacturing problems where observed.Complaint history shows previous events of this nature, with no historical escalations or corrective actions.The instructions for use contain comprehensive instructions on the safe operation and use of the device.The risk files mitigate the reported issue with no updates required.Smith and nephew can confirm the device was released according to specifications and continue to monitor for adverse trends relating to this product range.This investigation is now complete with no manufacturing problems observed 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 HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11709730
• MDR Text Key: 246960494
• Report Number: 8043484-2021-00922
• 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: K110958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2022

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 Operator: Health Professional
• Device Expiration Date: 12/13/2021
• Device Model Number: 66800041
• Device Catalogue Number: 66800041
• Device Lot Number: 50845605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2021
• Initial Date FDA Received: 04/22/2021
• Supplement Dates Manufacturer Received: 02/07/2022
• Supplement Dates FDA Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1