MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. VERSAJET II CONSOLE; LAVAGE, JET

Model Number	66800039
Medical Device Problem Codes	Failure to Prime (1492); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during debridement surgery, water failed to reach the handpiece of a versajet ii hydrosurgery system console.By the time this happened, the patient was already anaesthetized, and it was reported that a lot of time was lost in the operating room.The console started up properly.The purge was done, but there was no water in the handpiece.The procedure could not be successfully completed, for which it was cancelled and postponed.No injury caused to the patient.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during debridement surgery, water failed to reach the handpiece of a versajet ii hydrosurgery system console.By the time this happened, the patient was already anaesthetized, and it was reported that a lot of time was lost in the operating room.The console started up properly.The purge was done, but there was no water in the handpiece.The procedure could not be successfully completed, for which it was cancelled and postponed.No injury caused to the patient.
Additional Manufacturer Narrative
The investigation is now complete.The device was returned for evaluation and with no faults found, the event cannot be confirmed.A visual inspection observed signs of general wear and tear, the functional evaluation found no device faults.Utilizing a test handpiece, the device primed and operated within expected parameters.A documentation review has been conducted, confirming previous complaints of this nature, the device history and historical review have observed no manufacturing quality concerns.The risk files mitigate the reported event which is further delineated in the instruction for use (ifu).The root cause could not be determined as no fault was found.The ifu explicitly states to ensure that the device is fully primed and operational prior to the administration of anesthesia, to prevent unnecessary delays.No manufacturing related concerns have been identified, therefore no corrective action is deemed necessary.Smith and nephew can confirm the device was released according to specifications and continue to monitor for adverse trends relating to this product range.

• Brand Name: VERSAJET II CONSOLE
• 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: 13457972
• Report Number: 8043484-2022-00049
• Device Sequence Number: 19990532
• Product Code: FQH
• UDI-Device Identifier: 00040565124759
• UDI-Public: 00040565124759
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K143115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2022

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
• Operator of Device: Health Professional
• Device Model Number: 66800039
• Device Catalogue Number: 66800039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2022
• Supplement Date Received by Manufacturer: 03/26/2022
• Initial Report FDA Received Date: 02/04/2022
• Supplement Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown