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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the versajet ii exact disposable handpiece 45 degree x 14mm malfunctioned and has fluid spraying out.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
The device used in treatment was not returned for evaluation, all provided information has been reviewed and we have not been able to establish a relationship between the device and the reported event or determine a root cause.Probable root cause may include, kinks, leaks and blockages.A review of the manufacturing records found that there was no evidence that the product didn't meet specifications at the time of manufacture.A complaint history review found further instances of the reported event.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.
Additional Manufacturer Narrative
The device was returned for evaluation, confirming the reported event.Visual inspection noted no obvious defects, functional evaluation confirmed the device could not prime and leaked.The root cause of the reported leak is determined to be an assembly issue, a screen support was missing from the evaluated device.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 initiated.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 corrective actions deemed necessary at this time.

• 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: 12159815
• Report Number: 8043484-2021-01646
• Device Sequence Number: 3801146
• Product Code: FQH
• UDI-Device Identifier: 00040565124681
• UDI-Public: 00040565124681
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K143115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 02/04/2021
• Device Model Number: 66800041
• Device Catalogue Number: 66800041
• Device Lot Number: 50785775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2021
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/05/2021
• Supplement Date Received by Manufacturer: 09/17/2021; 02/08/2022
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 09/17/2021; 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2019
• 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
• Patient Sex: Unknown