MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. VERSAJET EXACT ASSY, 15 DEGREE X 14MM; LAVAGE, JET

Catalog Number 66800040

Device Problems Defective Device (2588); No Pressure (2994)

Patient Problems Tissue Damage (2104); No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2019

Event Type  malfunction  

Event Description

It was reported that when using the versajet, the supporting supply handle of versajet did not flow water.There were no delays and there was a backup available.The event happened during surgery and the physician had to change the technique to traditional debridement.No patient harm reported.

Manufacturer Narrative

The devices used in treatment have been received for evaluation.A visual inspection of both handsets found no defects, the functional evaluation was able to establish a relationship between the one of the handsets and the reported complaint.1.Handset 1 found no fault; the unit was bale to prime and operate correctly 2.Handset 2, following priming was found to not function correctly, the spray was not consistent.It was found following disassembly that the support screen was missing from this handset, preventing a consistent flow.A review of the device history showed that this unit passed all acceptance criteria and was compliant upon release for distribution.There were no indications to suggest the device did not meet product specifications nor did it allege any product deficiencies.Complaint history has been reviewed, which show a previous instance of this failure recorded.Failures are under constant review; however, it is deemed that no further action is necessary in relation to this complaint which has been closed and recorded as, no fault found for handset 1 and individual component failure for handset 2.The versajet system is a high-pressure device, which uses saline in its operation.Failures of this type can be caused by a build of oxidized saline.The instructions for use, details guidance on the maintenance and cleaning of the device.With specific guidance on the matter of corrosion.It is highly recommended that these instructions are followed to prevent re-occurrences of this type of failure.In parallel we continue to monitor for any adverse trends relating to this product range.Please be assured that all products are released to market following rigorous quality checks during production and prior to despatch.By acknowledging and investigating your complaint this collaboration enables us to drive our passion to continuously review, improve and steer our shared purpose of providing the best possible outcome for customer and patients.Smith and nephew take all customer complaints and concerns seriously, we strive to have the best understanding of our patients needs and have built a strong culture of care, collaboration and courage to offer a service which we are proud of.

• Brand Name: VERSAJET EXACT ASSY, 15 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
• MDR Report Key: 9596231
• MDR Text Key: 175229369
• Report Number: 8043484-2020-00035
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• PMA/PMN Number: K110958
• 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: 04/13/2020

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 Catalogue Number: 66800040
• Device Lot Number: 50800997
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/03/2020
• Initial Date FDA Received: 01/16/2020
• Supplement Dates Manufacturer Received: 04/08/2020
• Supplement Dates FDA Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other