MAUDE Adverse Event Report: MISONIX INC NEXUS; SONICONE OR SHARPVAC AND TUBESET

Model Number 120-31-13C2

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

The sales representative reported on (b)(6) 2020 that after "30 minutes of debriding with the nexus, patient experienced black dots." medical intervention (lavage of the affected area) to preclude injury with a delay in treatment was reported.A serious injury to the patient, or user was not reported.The returned device exhibited signs of thermal stress.The ifu contains the following warnings and cautions: warning: the nexus ultrasonic surgical aspirator system is intended to be used in various types of invasive, surgical procedures.There may be indirect danger to the patient should the device fail during the procedure.It is recommended that the facility follows its back-up equipment protocols.Warning: the system check should always be done in advance of preparing patient for surgery to minimize risk to patient in case of system malfunction.Warning: during system check, make sure the tip of the handpiece is free from contact with any object.Allowing contact with the tip may result in damage and/or personal injury caution: ultrasonic energy is inhibited if excessive physical force is applied to the ultrasonic tip; use only enough force to guide the tip to the surgical site and to advance it through the tissue.Do not force the tip; allow the ultrasonic action to do the work.Caution: insufficient irrigation and high tip pressure (loading) under extended exposure, e.G.In tight cavities, are to be avoided in hard tissue removal.It is recommended to withdraw and re-insert the ultrasonic tip repeatedly to re-establish adequate cooling and lubrication.Caution: it is strongly advised that a sterile backup handpiece be readily available in the operating room as insurance any contamination or malfunction of the handpiece used during surgery.

Event Description

The sales representative reported on (b)(6) 2020 that after, "30 minutes of debriding with the nexus, patient experienced black dots.".

• Brand Name: NEXUS
• Type of Device: SONICONE OR SHARPVAC AND TUBESET
• Manufacturer (Section D): MISONIX INC; 1938 new highway; farmingdale NY 11735
• Manufacturer (Section G): MISONIX INC; 1938 new highway; farmingdale NY 11735
• Manufacturer Contact: jenny cunniffe ; 1938 new highway; farmingdale, NY 11735
• MDR Report Key: 10648065
• MDR Text Key: 210673168
• Report Number: 2435119-2020-00005
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 00084162610310
• UDI-Public: 0084162610310
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2023
• Device Model Number: 120-31-13C2
• Device Lot Number: 203036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2019
• 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
• Patient Outcome(s): Required Intervention