MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VERSAJET HANDPIECES; LAVAG, JET

Lot Number 26714D

Device Problems Inaccurate Delivery (2339); Connection Problem (2900)

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

Event Date 12/15/2015

Event Type  malfunction  

Event Description

Inaccurate stream delivery was reported, the strength of the saline stream and the power of debridement was weaker han usual.The connection between the handpiece and the console was loose.

• Brand Name: VERSAJET HANDPIECES
• Type of Device: LAVAG, JET
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 970 lake carillon drive; suit 110; st petersburg FL 33716
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 970 lake carillon drive; suite 110; st petersburg FL 33716
• Manufacturer Contact: claudia odoy ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 5334179
• MDR Text Key: 35169850
• Report Number: 3006760724-2015-00126
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K110958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2015

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 Lot Number: 26714D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2015
• Initial Date FDA Received: 12/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1