MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEMENT VERSAJET II PLUS 15DEG X 14MM

Model Number 66800043

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/03/2014

Event Type  malfunction  

Event Description

During in use the versajet handpiece began rapidly sputter and there was not possibility to finish surgery.

Manufacturer Narrative

Active investigation in progress; results of investigation will be provided in a supplement report.

Manufacturer Narrative

The reported complaint was deemed inconclusive as no sample was received for evaluation.A device history record review was conducted for the lot # 13413j and no discrepancies were found during the manufacturing process for the batch of the versajet handpieces ii.A 20 minute functional leak test during the 5 min pressure test was performed and all samples were working within specifications.No quality issues, process deviation or changes to the process were found during the manufacturing of the lot 13413j.However, there are various known operating conditions that may lead to excessive ¿overspray¿ or mist during use of the versajet ii handpieces.Per the ifu, when used on wounds where bone, tendon or other dense tissue may be encountered during the debridement procedure, excessive spraying and/or misting may occur due to the interruption of the stream of sterile saline by hard tissue.Additionally, spraying and/or misting are more frequent at lower power settings due to less pressure.Spraying and/or misting may be reduced by keeping the waste evacuation tube straight.Lastly, if the device tip becomes blocked with foreign matter, a reduction in device efficiency or the presence of spray from the tip may result.To eliminate the obstruction, remove the handpiece from the wound site, release the foot pedal and remove the obstruction with forceps.Do not touch the opening in the high-pressure jet with forceps.Once the obstruction is removed, press the foot pedal and check for steady stream of sterile saline flow.If the obstruction is not completely removed, repeat procedure or check that the evacuation line is not pinched by forceps or being stepped on, or that the collection container is full.We will continue monitoring for this type of issues and if a trend develops corrective action will be taken at that time.

Event Description

During in use the versajet handpiece began rapidly sputter and there was not posibility to finish surgery.

• Brand Name: VERSAJET II PLUS 15DEG X 14MM
• Type of Device: VERSAJET II PLUS 15DEG X 14MM
• Manufacturer (Section D): SMITH & NEPHEW WOUND MANAGEMENT; 970 lake carillon drive; suite 110; st. petersburg FL 33716
• Manufacturer (Section G): SMITH & NEPHEW WOUND MANAGEMENT; 970 lake carillon drive; suite 110; st. petersburg FL 33716
• Manufacturer Contact: terry mcmahon ; 970 lake carillon drive; suite 110; st. petersburg, FL 33716 ; 7273993785
• MDR Report Key: 3651112
• MDR Text Key: 16799078
• Report Number: 3006760724-2014-00025
• 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: Foreign,Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/07/2014

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 Model Number: 66800043
• Device Lot Number: 13413J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/05/2014
• Initial Date Manufacturer Received: 02/05/2014
• Initial Date FDA Received: 02/27/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/08/2014
• Was Device Evaluated by Manufacturer?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other