MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEMENT VERSAJET II EXACT 45DEG X 14MM; LAVAGE, JET

Model Number 66800041

Device Problems Break (1069); Material Puncture/Hole (1504); Sparking (2595)

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

Event Date 05/30/2014

Event Type  malfunction  

Event Description

Damaged or broken component.Hand piece was being used effectively until saline bag needed to be changed.The surgeon tried to re-prime the hand piece.No saline was running through the hand piece, no obvious air in tubing was evident and the foot pedal was depressed for up to two minutes.At that point, the hand piece erupted followed by two loud bangs and spark from the hand piece.Two eruption sites (puncture marks) were evident on the tubing.

Event Description

Damaged or broken component.Hand piece was being used effectively until saline bag needed to be changed.The surgeon tried to re-prime the hand piece.No saline was running through the hand piece, no obvious air in tubing was evident and the foot pedal was depressed for up to two minutes.At that point, the hand piece erupted followed by two loud bangs and spark from the hand piece.Two eruption sites (puncture marks) were evident on the tubing.

Manufacturer Narrative

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

• Brand Name: VERSAJET II EXACT 45DEG X 14MM
• Type of Device: LAVAGE, JET
• 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: 3865340
• MDR Text Key: 4933621
• Report Number: 3006760724-2014-00379
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K110958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 66800041
• Device Lot Number: 09813LY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/30/2014
• Date Manufacturer Received: 05/30/2014
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1