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

Model Number	66800039
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device, intended for use in treatment, was returned for evaluation.The visual evaluation found the footswitch port damaged.The functional evaluation was unable to test footswitch ,due to the port been damaged, establishing a relationship between the device and the reported event.The root cause was identified as a damaged component.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found other related events.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.Case: (b)(4).
Event or Problem Description
It was reported that an unspecified malfunction occurred with the versajet ii console.No case was involved.During product investigation it was found that the visual evaluation found the footswitch port damaged.The functional evaluation was unable to test footswitch due to the port been damaged.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: VERSAJET II CONSOLE
• Common Device Name: 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: 12368480
• Report Number: 8043484-2021-01692
• Device Sequence Number: 4115458
• Product Code: FQH
• UDI-Device Identifier: 00040565124759
• UDI-Public: 00040565124759
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K143115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/25/2021

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
• Operator of Device: Health Professional
• Device Model Number: 66800039
• Device Catalogue Number: 66800039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 08/25/2021
• Patient Sequence Number: 1