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

Model Number 66800041

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/11/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

It was reported that, during the preparation of debridement utilizing a versajet, a leakage occurred from the orange cartridge´s hand-piece.The surgery was completed with a surgical knife.No patient harm and no delay was reported.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 returned for evaluation, establishing a relationship between the reported event and device.A visual inspection was performed and showed no damage to the device.Functional inspection was performed and showed the feed line tubing was easily removed from the feed line fitting of the pump cartridge.There appeared to be adhesive residue within the feed line at the connection point.The root cause is determined to be a failure in the manufacturing process.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.Instructions for use (ifu) contains recommendations and precautionary statements for proper use of product.A clinical/medical assessment was performed and determined no further actions are required.Smith and nephew will continue to monitor for any adverse trends relating to this product.No further investigation is required.

• 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: 10955754
• MDR Text Key: 219849000
• Report Number: 8043484-2020-04085
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00040565124681
• UDI-Public: 00040565124681
• 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: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2021
• Device Model Number: 66800041
• Device Catalogue Number: 66800041
• Device Lot Number: 50789159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 12/06/2020
• Supplement Dates Manufacturer Received: 05/12/2021
• Supplement Dates FDA Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention