MAUDE Adverse Event Report: MICROAIRE SURGICAL INSTRUMENTS, LLC MICROAIRE CANNULA; 4.0MM MULTI-USE CANNULA

Model Number	PAL-R408LL
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Customer has reported that during a liposuction procedure, the tip of the liposuction cannula broke off in the patient's sub-cutaneous tissue.It was necessary for the patient to receive an x-ray and for the tip to be extracted.This extended the procedure by approximately one (1) hour.There was no patient injury.

• Brand Name: MICROAIRE CANNULA
• Common Device Name: 4.0MM MULTI-USE CANNULA
• Manufacturer (Section D): MICROAIRE SURGICAL INSTRUMENTS, LLC; 3590 grand forks boulevard; charlottesville, va
• MDR Report Key: 9802781
• Report Number: 2020601-2020-00194
• Device Sequence Number: 834994
• Product Code: MUU
• UDI-Device Identifier: 00847399009234
• UDI-Public: 00847399009234
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K981922
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: PAL-R408LL
• Device Catalogue Number: PAL-R408LL
• Device Lot Number: 0818329022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other