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

Model Number 66800041

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 09/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported there was abnormal misting, spitting from the connected part of the hand-piece.

• Brand Name: VERSAJET II EXACT 45DEG X 14MM
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 970 lake carillon drive; st petersburg FL 33716
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76. s meridan avenue; oklahoma city OK 73107
• Manufacturer Contact: claudia odoy ; schachenallee 29; aarau 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 5959709
• MDR Text Key: 55366845
• Report Number: 3006760724-2016-00139
• 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: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/07/2016

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: 66800041
• Device Catalogue Number: 66800041
• Device Lot Number: 50590113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2016
• Initial Date FDA Received: 09/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/25/2016
• Was Device Evaluated by Manufacturer?: No
• 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