MAUDE Adverse Event Report: MISONIX, INC. SONASTAR® SHORT STRAIGHT 23 KHZ UNIVERSAL HANDPIECE; ULTRASONIC SURGICAL SYSTEM HANDPIECE

Model Number CSFX6-H221

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 03/15/2022

Event Type  malfunction  

Event Description

On april 15, 2022, misonix received a product occurrence report on a sonastar® short straight 23 khz universal handpiece (part number csfx6-h221, serial number (b)(4)) that occurred on (b)(6) 2022, during a cranial tumor resection.A serious injury to the patient or user was not reported, however there was a delay in treatment greater than 15 minutes.Medical intervention required to preclude serious injury was not reported.

Manufacturer Narrative

On april 15, 2022, misonix received a product occurrence report on a sonastar® short straight 23 khz universal handpiece (part number csfx6-h221, serial number (b)(4)) that occurred on (b)(6) 2022, during a cranial tumor resection.A serious injury to the patient or user was not reported; however, there was a delay in treatment greater than 15 minutes.Medical intervention required to preclude serious injury was not reported.The device history record for the subject handpiece was reviewed.The handpiece met all specifications prior to release to commerce.The returned handpiece was evaluated, and the complaint confirmed.The handpiece did not meet specifications.A single fault condition was identified.The system meets the requirements for leakage current in accordance with ul 60601-1 medical electrical equipment, part 1: general requirements for safety, and iec 60601-1 medical electrical equipment part 1: general requirements for basic safety and essential performance (3rd edition) for all normal and single fault conditions for type b applied parts.Specifically, the generator console monitors the electrical output to the handpiece at all times.If there is an imbalance of current the generator automatically disables the ultrasound output to prevent unsafe patient or user leakage current.Fault codes are displayed on the front panel and an audible tone can be heard.The patient circuit is a floating ground, limiting leakage current.The ifu lists corrective actions to clear fault messages or return the device to misonix if fault messages recur.The instructions for use manual (ifu-601, revision s) for sonastar® models with serial #'s that begin with flv contains the following caution to mitigate harm from delay in treatment: caution: it is strongly advised that a sterile backup handpiece be readily available in the operating room as insurance against any contamination or malfunction of the handpiece during surgery.A complete list of all warnings, cautions and notes can be found in chapter 1 of the ifu.No increasing trends on the single fault have been identified for part number csfx6-h221.The current frequency is below the likelihood of occurrence in the risk management report.There is no change in residual risk or risk-benefit.

• Brand Name: SONASTAR® SHORT STRAIGHT 23 KHZ UNIVERSAL HANDPIECE
• Type of Device: ULTRASONIC SURGICAL SYSTEM HANDPIECE
• Manufacturer (Section D): MISONIX, INC.; 1938 new hwy; farmingdale NY 11735
• Manufacturer (Section G): MISONIX, INC.; 1938 new hwy; farmingdale NY 11735
• Manufacturer Contact: john salerno ; 1938 new hwy; farmingdale, NY 11735 ; 6319279123
• MDR Report Key: 14461763
• MDR Text Key: 300355087
• Report Number: 2435119-2022-00004
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062471
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CSFX6-H221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2022
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other