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

Catalog Number 66800039

Device Problems Inaccurate Flow Rate (1249); Noise, Audible (3273)

Patient Problems Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2020

Event Type  Injury  

Event Description

It was reported that with 2 recent cases the dr.Had difficulty getting the adequate pressure through the operating window and saline was leaking badly at the handset connector.The versajet handsets failed to perform as expected.In both cases the treatment had to be finished he case with sharp debridement.It was also reported that the console was also making a loud noise, it appeared that the noise got progressively worse as the versajet ii continued to run.

Manufacturer Narrative

The device used in treatment has not been returned for evaluation, with no additional information provided.We have not been able to establish a relationship between the device and the reported event or determine a root cause on this occasion.Factors that can contribute include, difficulty to interlock, blockages, kinks, the unique interface maybe out of alignment or corroded, noise could be due to the device requiring servicing.The instructions for use provide comprehensive instructions of the operation, use and limitations of the device.The associated risk files contain the reported failure/harm or event.However, as no harm has been alleged then additional review is not required.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history file contains further instances the reported events, however this investigation is now complete.

• Brand Name: VERSAJET II CONSOLE
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: sarah freestone ; 101 hessle road; hull HU3 2-BN ; UK HU3 2BN ; 4407940038
• MDR Report Key: 10084345
• MDR Text Key: 192134054
• Report Number: 8043484-2020-00516
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 04582111153524
• UDI-Public: 4582111153524
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66800039
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/24/2020
• Date Manufacturer Received: 12/11/2020
• 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
• Patient Outcome(s): Required Intervention