MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. VERSAJET EXACT ASSY, 45 DEGREE X 14MM; LAVAGE, JET

Model Number	66800041
Medical Device Problem Codes	Obstruction of Flow (2423); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that a versajet ii hydrosurgery system handset, 45deg 14mm exact was not performing correctly.The tip seemed to be "bent" and the stream was affected.Surgery was performed, after a non-significant delay, with a back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.An obstruction of flow would not be likely to cause or contribute to death or serious injury, even in a clinical setting.Additional conditions must also exist (e.G., surgical/ treatment conditions; patient factors; the unavailability of back-up or alternate therapies for greater than 24 hours; surgical delay greater than 30 minutes) before an injury could occur, and even under those conditions, the risk of patient harm is low.This event did not lead to a death or serious injury, nor would it be likely to cause or contribute to a death or serious injury if it were to recur.This event is considered not reportable pursuant to 21 cfr §803.

• Brand Name: VERSAJET EXACT ASSY, 45 DEGREE X 14MM
• 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: 12979016
• Report Number: 8043484-2021-02015
• Device Sequence Number: 4217179
• Product Code: FQH
• UDI-Device Identifier: 00040565124681
• UDI-Public: 00040565124681
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K143115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2022

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: 08/31/2023
• Device Model Number: 66800041
• Device Catalogue Number: 66800041
• Device Lot Number: 50963209
• 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: 11/22/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 12/10/2021
• Supplement Report FDA Received Date: 05/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2021
• 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 Sex: Unknown