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

Model Number 66800045

Device Problems Burst Container or Vessel (1074); Material Rupture (1546)

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

Event Date 01/20/2022

Event Type  malfunction  

Event Description

It was reported that, during the set up for a debridement treatment, the water hose of a versajet ii hydrosurgery system handset, 45deg 8mm plus burst at the transition to the handpiece.Treatment was performed, without any delay, with a back-up device instead.Patient was not injured as consequence of this problem.

Manufacturer Narrative

Internal complaint reference: case (b)(4).

Manufacturer Narrative

Internal complaint reference: case (b)(4).

Event Description

It was reported that, during the set up for a debridement treatment, the water hose of a versajet ii hydrosurgery system handset, 45deg 8mm plus burst at the transition to the handpiece.Treatment was performed, without any delay, with a back-up device instead.Patient was not injured as consequence of this problem.

Manufacturer Narrative

Updated b5, h2, h3, h6.The investigation into the reported event is now complete, the complained device has not been returned for evaluation, the event cannot be confirmed.A documentation review, observed no historical, manufacturing or quality concerns.The reported event is adequately mitigated within the risk files, the instruction for use, (ifu), provides adequate delineation.The ifu calls out in set-up, "ensure there are no kinks or other external obstructions in saline supply, high-pressure and waste evacuation hoses".With no manufacturing problems observed, no corrective actions are deemed necessary.The probable root cause may include hose rupture due to a kink within the hose.Smith and nephew can confirm the device was released according to specifications and continue to monitor for adverse trends relating to this product range.

Event Description

It was reported that, during the set up for a debridement treatment, the water hose of a versajet ii hydrosurgery system handset, 45deg 8mm plus burst at the transition to the handpiece.Treatment was performed, without any delay, with a back-up device instead.Patient was not injured as consequence of this problem.

• Brand Name: VERSAJET PLUS 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13501815
• MDR Text Key: 285925816
• Report Number: 8043484-2022-00056
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00040565124780
• UDI-Public: 00040565124780
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K143115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2022
• Device Model Number: 66800045
• Device Catalogue Number: 66800045
• Device Lot Number: 50879302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2022
• Date Device Manufactured: 06/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1