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

Model Number 66800039

Device Problems Display or Visual Feedback Problem (1184); Defective Component (2292); Protective Measures Problem (3015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/12/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that the nurse was setting up the versajet for a surgery and when he turned the unit on he noticed the following: the power display was blank- no numbers showing in the screen.The footswitch connect indicator led was illuminated.System fault indicator was also illuminated.When the pump cartridge was turned from unlocked to locked, the green light wasn't illuminated.Press on footswitch pedal and nothing happened.The versajet was not used for the procedure, and there was no harm to the patient.The procedure was completed using curettes and scalpel with no delay.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 that was intended for use in treatment was not returned for evaluation, with all information provided we have not been able to establish a relationship between the device and the reported event or determine a root cause.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 failures.The associated risk files contain the reported failure/harm or event.However, as no harm has been alleged then additional review is not required.Instructions for use (ifu) contains recommendations and precautionary statements for proper use of product.Factors that are known to contribute to the alleged fault/failure may be a connection issue or component failure.This investigation is now complete with no further action deemed necessary.Smith and nephew will continue to monitor for any adverse trends relating to this product range.

• 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: 11364796
• MDR Text Key: 233035109
• Report Number: 8043484-2021-00379
• 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: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1