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

Model Number	66800042
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blister (4537)
Date of Event	11/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during surgical debridement, the versajet exact assy, 45 degree x 8mm made little blisters on the skin.Patient is (b)(6) baby with 44% burns of boiling water.Skin was extremely red (more than would have been expected).No extra treatment was given: the versajet was discontinued and acticoat was placed on the wound area, which was the plan before the blistering happened.Patient outcome is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation, however the supplied images have been evaluated and confirm the reported event.The instruction for use details how the device can cut soft tissue.Apply only to tissues and debris intended to be excised from the wound.Medical review concluded, a procedural variance cannot be ruled out as a contributing factor to the reported event, which does not represent a device malfunction.Therefore, the impact to the patient beyond that which has already been reported cannot be determined.Should any additional relevant clinical information be provided, this complaint will be re-assessed.No further medical assessment is warranted at this time.A documentation review has been conducted, finding no previous complaints of this nature.No historical escalations or manufacturing problems were observed.A review of the device history confirmed that no manufacturing problems where observed.The instructions for use contain comprehensive instructions on the safe operation and use of the device.The risk files mitigate the reported issue with no updates required.This investigation is now complete, with no manufacturing problems observed, no corrective actions are 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 EXACT 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: 13013318
• Report Number: 8043484-2021-02020
• Device Sequence Number: 5441389
• Product Code: FQH
• UDI-Device Identifier: 00040565124698
• UDI-Public: 00040565124698
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K143115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/11/2022
• Device Model Number: 66800042
• Device Catalogue Number: 66800042
• Device Lot Number: 50906000
• 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: 11/28/2021
• Supplement Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2020
• 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: A
• Patient Sequence Number: 1
• Patient Age: 18 MO
• Patient Sex: Unknown