MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. VERSAJET EXACT ASSY, 45 DEGREE X 8MM; LAVAGE, JET

Model Number 66800042

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

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

Event Date 01/31/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during treatment a cable came loose with a high pressure leak.The canisters (jar) used to collect the water and debris residue has multiple valves, the user forgot to open the valves, so a vacuum was created.The force created a high pressure leak.There was a delay greater than 30 minutes, backup was available and used.No patient harm was reported.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation.A photo was provided for review and we could establish a relationship between the reported event and the device.The root cause was determined to be user error as stated in the complaint, the user forgot to open the valves causing the failure.A review of the manufacturing records could not be performed because the lot number was not provided.The complaint history review found further instances of the reported event.This investigation is now complete with no further action deemed necessary.We will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: VERSAJET EXACT ASSY, 45 DEGREE X 8MM
• 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: 11376285
• MDR Text Key: 233440914
• Report Number: 8043484-2021-00395
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00040565124698
• UDI-Public: 00040565124698
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 66800042
• Device Catalogue Number: 66800042
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1