MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEMENT VERSAJET SYSTEMS

Model Number VERSAJET SYSTEMS

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 02/03/2014

Event Type  malfunction  

Event Description

Failure/difficulty to interlock unable to use device during procedure.

Manufacturer Narrative

Active investigation in progress; results of investigation will be provided in a supplement report.We are submitting one (1) initial, 30 day report, medwatch fda form 3500a, for a purported device malfunction which occurred while using the versajet system.

Manufacturer Narrative

The reported complaint was deemed confirmed by description as a known issue.No lot number was provided and no sample was returned for evaluation so a review of manufacturing records could not be performed and a definitive root cause for the issue could not be identified.However, based on previous investigations of the handpiece being difficult to insert into the console, the most probable causes include misalignment between the console transmission, user interface and handset pump body, migration of the securing pins in the handset and/or corrosion of the moving parts inside the console.Additionally, variations in the current assembly process of the console and the handpiece may also have contributed to the reported issue.Corrective action (car-02486) was initiated in q1-2013 to investigate handpiece loading/unloading/interlocking difficulties.Component specifications and material changes for the user interface of the console have been implemented to ease assembly, reduce misalignment between parts, eliminate galvanic corrosion, improve the finish of mating surfaces and mistake-proof the assembly process.Additional improvements to the handset assembly process are currently being evaluated including the use of a pneumatic press alignment fixture and a proud pin detection fixture.No further corrective action will be taken at this time.Future product complaints will continue to be tracked and trended to detect any recurring issues and if needed, additional corrective action(s) will be initiated at that time.Based on information provided, the reported event did not result in patient injury or adverse event.

Event Description

Failure/difficulty to interlock unable to use device during procedure.

• Brand Name: VERSAJET SYSTEMS
• Type of Device: VERSAJET SYSTEMS
• Manufacturer (Section D): 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: 3724849
• MDR Text Key: 20716400
• Report Number: 3006760724-2014-00054
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K991383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/08/2014

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: Physician
• Device Model Number: VERSAJET SYSTEMS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/05/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/05/2014
• Initial Date FDA Received: 04/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other