MAUDE Adverse Event Report: MICROAIRE SURGICAL INSTRUMENTS MICROAIRE LIPOFILTER

Model Number ASP-CAN-2S

Device Problem Suction Problem (2170)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/06/2015

Event Type  malfunction  

Manufacturer Narrative

Disposed of by facility.

Event Description

Facility reported fat aspirate contents were unable to be suctioned out without losing fat cells for grafting.All fluids had to be manually drawn off and separated.No injuries were reported.During a file review, it was discovered that this is a reportable event that was inadvertently not reported.

Manufacturer Narrative

Device disposed of by facility.

Manufacturer Narrative

Follow-up #1; 04/12/2016: added "patient identifier".Follow-up #2; 04/14/2016: capa (b)(4) has been opened to address this issue.Disposed of by facility.

• Brand Name: MICROAIRE LIPOFILTER
• Type of Device: LIPOFILTER
• Manufacturer (Section D): MICROAIRE SURGICAL INSTRUMENTS; 3590 grand forks boulevard; charlottesville VA 22911
• Manufacturer (Section G): MICROAIRE SURGICAL INSTRUMENTS; 3590 grand forks boulevard; charlottesville VA 22911
• Manufacturer Contact: donna elliott ; 3590 grand forks boulevard; charlottesville, VA 22911 ; 4349758370
• MDR Report Key: 5512636
• MDR Text Key: 41023783
• Report Number: 2020601-2016-00014
• Device Sequence Number: 1
• Product Code: MUU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/30/2017
• Device Model Number: ASP-CAN-2S
• Device Catalogue Number: ASP-CAN-2S
• Device Lot Number: 0815276724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1