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

Model Number	66800039
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).
Event or Problem Description
It was reported that, a renasys go was overheating no case involved; therefore, no patient injuries or other complications were reported.No further information is available.
Additional Manufacturer Narrative
H3, h6: the device was returned for evaluation, however the reported event could not be confirmed.Visual inspection found general wear to device.Functional evaluation found that the device operated as intended with no faults found with no notable overheating.Probable root cause of the reported failures may be user not anticipating the heat generated by the device under normal use conditions.The device instructions for use highlights how the device may heat up during use, due to the nature of the mechanical components within.A documentation investigation has been conducted, confirming that no manufacturing problems have been observed.Complaint history shows previous events of this nature.No manufacturing issue has been confirmed in relation to these complaints.The instructions for use and risk files, mitigate the reported issue with no updates required.Smith and nephew can confirm the device was released according to specifications and continue to monitor for adverse trends relating to this product range.This investigation is now complete with no additional corrective actions deemed necessary.

• 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13830770
• Report Number: 8043484-2022-00107
• Device Sequence Number: 19218731
• Product Code: FQH
• UDI-Device Identifier: 00040565124759
• UDI-Public: 00040565124759
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K143115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2022
• Supplement Date Received by Manufacturer: 03/25/2022
• Initial Report FDA Received Date: 03/20/2022
• Supplement Report FDA Received Date: 03/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown