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

Catalog Number 66800039

Device Problem Electrical Power Problem (2925)

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

Event Date 11/19/2019

Event Type  malfunction  

Event Description

It was reported that during an unknown procedure, the console would not power up.Fuses blown.

• Brand Name: VERSAJET II CONSOLE
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• 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 ; 4407940038
• MDR Report Key: 9483361
• MDR Text Key: 172031798
• Report Number: 8043484-2019-00922
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2020

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: No Information
• Device Catalogue Number: 66800039
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 12/15/2020
• 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