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

Model Number 66800039

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 01/13/2015

Event Type  malfunction  

Event Description

The console did not work when the foot pedal was pressed.The same problem occurred after changing to another pedal.This caused an hour delay to the procedure while the patient was anesthetized.An alternate treatment (manual debridement) was used and the procedure complete successfully.No harm to patient reported.

Event Description

The console did not work when the foot pedal was pressed.The same problem occurred after changing to another pedal.This caused an hour delay to the procedure while the patient was anesthetized.An alternate treatment (manual debridement) was used and the procedure complete successfully.No harm to patient reported.

Manufacturer Narrative

• Brand Name: VERSAJET II CONSOLE
• Type of Device: LAVAGE, JET
• 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: 4517375
• MDR Text Key: 5950413
• Report Number: 3006760724-2015-00011
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2015
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1