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

Model Number 66800041

Device Problem Connection Problem (2900)

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

Event Date 04/26/2021

Event Type  malfunction  

Manufacturer Narrative

Case: (b)(4).

Event Description

It was reported that, during a hidrosurgery with versajet exact assy, 45 degree x 14mm.The water jet port of the new handle could not be connected with the drain port, so the water splashed around when it was working.The event occurred during use external to patient.The procedure was successfully completed with a no significant delay using a smith and nephew back up device.Patient was not harmed.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device, used in treatment, has been returned and evaluated.Visual inspection reported the distal tip of the device appears to have either corrosion crystallization or bio-burden around the distal output orifice.The functional evaluation confirmed that the unit had priming issues, establishing a relationship between the device and the reported events.The root cause identified as an obstruction.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 further instances of the reported event.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

Manufacturer Narrative

H3, h6: the device, used in treatment, has been returned and evaluated.Visual inspection reported the distal tip of the device appears to have either corrosion crystallization or bio-burden around the distal output orifice.The functional evaluation found the device connected as intended, which could not establish a relationship between the device and the reported event, further evaluation indicated the device had priming issues and blockage at the tip.Probable root cause is an obstruction.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 further instances of the reported event.This investigation is now complete with no further action deemed necessary.Smith + 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: 11814163
• MDR Text Key: 250267538
• Report Number: 8043484-2021-01093
• 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: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2021

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: Other
• Device Expiration Date: 11/14/2021
• Device Model Number: 66800041
• Device Catalogue Number: 66800041
• Device Lot Number: 50839893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2021
• Initial Date Manufacturer Received: 04/26/2021
• Initial Date FDA Received: 05/12/2021
• Supplement Dates Manufacturer Received: 07/14/2021; 09/13/2021
• Supplement Dates FDA Received: 07/15/2021; 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1