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

Catalog Number 50636

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/06/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, during treatment, 2 versajet assy, 45 degree x 14mm, gen ii had a leak within the actual hand piece, and water was shooting out of the handle.Also, another versajet assy, 45 degree x 14mm, gen ii had a very low flow and was vibrating.Treatment was resumed, after a non-significant delay, it is unknown how the treatment was finished.Patient was not harmed as consequence of this problem.

Manufacturer Narrative

H10: in reviewing the description of the occurrence, it was determined that this event did not lead to death or serious deterioration in the state of health of a patient, user or other person.Although a device malfunction, procedure was finished as intended without any other medical intervention with the same or equivalent device with no significant delay or complication.The malfunction did not cause or contribute to a serious injury or death and it is not likely to cause or contribute to a serious injury or death if the malfunction were to recur.This event is considered not reportable pursuant to 21 c.F.R.§803.Internal complaint reference number: (b)(4).

• Brand Name: VERSAJET ASSY, 45 DEGREE X 14MM, GEN II
• Type of Device: 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: 12712567
• MDR Text Key: 278818309
• Report Number: 8043484-2021-01916
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 04582111153098
• UDI-Public: 4582111153098
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/04/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 50636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/07/2021
• Initial Date FDA Received: 10/28/2021
• Supplement Dates Manufacturer Received: 04/04/2022
• Supplement Dates FDA Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1