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

Model Number 66800039

Device Problem Noise, Audible (3273)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 10/12/2020

Event Type  Injury  

Event Description

¿it was reported that, when the foot pedal was initially depressed, the console made a loud grinding noise and pumped the fluid to the handpiece very slowly.It was tried to replace the handpiece but it was unable to get the original handpiece to dislodge from the console.The doctor proceeded using standard debridement tools without delay.Patient injuries were not reported.¿.

Manufacturer Narrative

H3, h6: the device used in treatment was returned for evaluation.A relationship between the reported event and device could be established.A visual inspection was performed and showed no damage to the device.Functional inspection was performed and showed the pump cartridge was found stuck in u.I.Assembly.The root cause is determined to be a component failure.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.A complaint review indicated other failures reported.The associated risk files contain the reported failure/harm or event.Instructions for use (ifu) contains recommendations and precautionary statements for proper use of product.A clinical/medical assessment was performed and determined no further actions are required.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for adverse trends related to this product.

• 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
• MDR Report Key: 10799932
• MDR Text Key: 214995089
• Report Number: 8043484-2020-03768
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00040565124759
• UDI-Public: 00040565124759
• Combination Product (y/n): N
• PMA/PMN Number: K110958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 66800039
• Device Catalogue Number: 66800039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Date Manufacturer Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention