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

Catalog Number 66800039

Device Problems Inaccurate Flow Rate (1249); No Pressure (2994)

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

Event Date 11/05/2019

Event Type  malfunction  

Event Description

It was reported that the device was not generating enough pressure at any level to remove tissue.Two pieces were tested and no success was achieved.The technique had to be changed to a traditional procedure using blades.

• Brand Name: VERSAJET II CONSOLE
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull ; UK
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: sarah freestone ; 101 hessle road; hull HU3 2-BN ; UK HU3 2BN ; 0447940038
• MDR Report Key: 9425677
• MDR Text Key: 169687126
• Report Number: 8043484-2019-00886
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/11/2021

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 Catalogue Number: 66800039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 03/08/2021
• Supplement Dates FDA Received: 03/11/2021
• Was Device Evaluated by Manufacturer?: No
• 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