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

Model Number 66800039

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2020

Event Type  malfunction  

Event Description

It was reported that during treatment a leak started at the pump interface so the use was stopped.It is unknown how was treatment completed.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: the device used in treatment was returned for evaluation.A relationship between the reported event and device could not be established.A visual inspection was performed and showed no damage to the device.Functional inspection was performed and showed the device functioned as intended.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.Probable root cause is a connection issue or component failure.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 east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10857662
• MDR Text Key: 216819209
• Report Number: 8043484-2020-03896
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00040565124759
• UDI-Public: 00040565124759
• Combination Product (y/n): N
• PMA/PMN Number: K143115
• 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: 05/13/2021

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 Model Number: 66800039
• Device Catalogue Number: 66800039
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 05/12/2021
• Supplement Dates FDA Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1