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

Model Number 66800041

Device Problem No Flow (2991)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/22/2020

Event Type  Injury  

Event Description

It was reported that fluid did not flow out the versajet handpiece hence it could not be used.The doctor used another product to do a washout of the wound and then a vac dressing was applied.A small delay was reported.No patient harm reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device, intended for use treatment was not returned for evaluation with all additional information provided we have not been able to establish a relationship between the reported event or determine a root cause.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 was performed for the product and failure mode reported, there have been further instances in the past three years.Probable cause may be an obstructed fluid supply.The ifu has been reviewed and contains comprehensive instructions on the safe operation and use of the device.The associated risk files contain the reported failure/harm or event.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.Smith and nephew will continue to monitor for any adverse trends relating to this product.No further investigation is required.

• 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
• MDR Report Key: 10852664
• MDR Text Key: 216635105
• Report Number: 8043484-2020-03877
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00040565124681
• UDI-Public: 00040565124681
• Combination Product (y/n): N
• PMA/PMN Number: K143115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 66800041
• Device Catalogue Number: 66800041
• Device Lot Number: 50807671
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention