MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. VERSAJET EXACT ASSY, 45 DEGREE X 14MM; LAVAGE, JET

Catalog Number 66800041

Device Problems Failure to Prime (1492); Connection Problem (2900)

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

Event Date 05/04/2021

Event Type  malfunction  

Event Description

It was reported that the pump of the versajet ii console was not working properly, further details not provided.No case involved; therefore, there was no patient involvement.

Event Description

It was reported that the hand piece was not pumping/primimg and the water was not pumping from the console.No case involved; therefore, there was no patient involvement.

Manufacturer Narrative

Additional information: b4.D4.D1, h6.

Manufacturer Narrative

H3, h6: the device that was intended for use in treatment was not returned for evaluation with all information provided we could not establish a relationship between the device and the reported event.Probable root cause may include a set up issue or component failure.No lot/serial number has been provided; therefore, a review is not possible.A complaint history review found other failures related to the report event.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 EXACT ASSY, 45 DEGREE X 14MM
• 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: 11907532
• MDR Text Key: 253599587
• Report Number: 8043484-2021-01287
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• PMA/PMN Number: K143115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66800041
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1