MAUDE Adverse Event Report: MICROAIRE MICROAIRE CANNULA; SYSTEM, SUCTION, LIPOPLASTY

Catalog Number	PAL - 600E
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During liposuction case the microaire liposuction handpiece was working intermittently during case.Since it was not working properly surgeon decided to stop using the device and continued the liposuction manually.

• Brand Name: MICROAIRE CANNULA
• Common Device Name: SYSTEM, SUCTION, LIPOPLASTY
• Manufacturer (Section D): MICROAIRE; 3590 grand forks blvd; charlottesville VA 22911
• MDR Report Key: 11313179
• Report Number: 11313179
• Device Sequence Number: 16011131
• Product Code: MUU
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2018
• Report Date (Section F): 02/03/2021

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: No Information
• Device Catalogue Number: PAL - 600E
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 02/11/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 02/03/2021