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

Model Number	66800039
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during procedure with versajet ii console utilizing a versajet ii handpiece in a surgical case, the carbon connected to the handpiece popped.The pop of carbon caused the fiber to hit the surgeon.It is unknown how the problem was solved or if there was a delay due to this event.No other complications reported.
Additional Manufacturer Narrative
The device was returned for evaluation, with no faults found the event is not confirmed.A visual inspection noted no defects.A functional evaluation found no fault, confirming that a device malfunction did not contribute to the event.A documentation review has confirmed that this device was manufactured and released according to the final product specification, with no contributory factors regarding the reported event.Historical records reviewed, contain reports of a similar nature, with no manufacturing or quality concerns observed, there are no open corrective actions.The risk files mitigate the reported event, which is further delineated within the instruction for use "ifu", which provides the probable root cause.A probable root cause may include, kinks or other external obstructions in saline supply, high-pressure and waste evacuation hoses".The ifu offers further guidance.No manufacturing quality concerns have been observed, therefore no corrective actions are deemed necessary, smith and nephew will continue to monitor for adverse trends relating to the reported allegation.
Additional Manufacturer Narrative
H6 has been corrected.

• 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: 13664067
• Report Number: 8043484-2022-00087
• Device Sequence Number: 11239393
• Product Code: FQH
• UDI-Device Identifier: 00040565124759
• UDI-Public: 00040565124759
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K143115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 06/22/2022; 06/22/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 06/22/2022; 12/06/2022
• 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