MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VERSAJET II EXACT 45DEG X 8MM HANDPIECE; LAVAGE, JET

Model Number 66800042

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 11/24/2015

Event Type  malfunction  

Event Description

It was reported that the suction was not working properly during the procedure, so the saline was gathered on the affected area and splashed.There was a 10 min delay.

• Brand Name: VERSAJET II EXACT 45DEG X 8MM HANDPIECE
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 970 lake carillon dr; st petersburg FL 33716
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 970 lake carillon dr; st petersburg FL 33716
• Manufacturer Contact: claudia odoy ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 5322001
• MDR Text Key: 34915794
• Report Number: 3006760724-2015-00122
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 66800042
• Device Catalogue Number: 66800042
• Device Lot Number: 50555509
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2015
• 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