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

Model Number	66800045
Medical Device Problem Codes	Burst Container or Vessel (1074); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 8043484-2022-00056
• Device Sequence Number: 14432047
• Product Code: FQH
• UDI-Device Identifier: 00040565124780
• UDI-Public: 00040565124780
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K143115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2022

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2022
• Supplement Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 04/06/2022
• Date Device Manufactured: 06/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown