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 01/12/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during treatment the line of the versajet ii hydro surgery system handpiece was leaking out of handpiece.The physician used a new versajet to continue with the procedure.No patient harm reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device that was used in treatment was not returned for evaluation photos were provided for review and could establish a relationship between the reported event and device however a root cause could not be determined.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.Probable cause may be a component failure or connection issue.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: 11269555
• MDR Text Key: 230013689
• Report Number: 8043484-2021-00233
• 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: 05/05/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2021
• Device Model Number: 66800041
• Device Catalogue Number: 66800041
• Device Lot Number: 50784149
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/12/2021
• Initial Date FDA Received: 02/02/2021
• Supplement Dates Manufacturer Received: 04/21/2021
• Supplement Dates FDA Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1