MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VERSAJET II CONSOLE

Model Number 66800039

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 11/25/2014

Event Type  malfunction  

Event Description

The handpiece could not be locked into the console causing over an hour delay to the procedure while the patient was anesthetized.An alternate treatment (manual debridement) was used and the procedure complete scornfully.No harm to patient reported.

• Brand Name: VERSAJET II CONSOLE
• Type of Device: VERSAJET II CONSOLE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 970 lake carillon dr.; suite 110; st. petersburg FL 33716
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 970 lake carillon dr.; suite 110; st. petersburg FL 33716
• Manufacturer Contact: terry mcmahon ; 970 lake carillon dr.; suite 110; st. petersburg, FL 33716 ; 7273993785
• MDR Report Key: 4517377
• MDR Text Key: 21081001
• Report Number: 3006760724-2015-00010
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K110958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/29/2015

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: Physician
• Device Model Number: 66800039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/21/2015
• Initial Date FDA Received: 02/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1