MAUDE Adverse Event Report: MICROAIRE SURGICAL INSTRUMENTS MICROAIRE CANNULA; TRI-PORT II CANNULA

Model Number PAL-506LL

Device Problem Suction Problem (2170)

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

Event Date 08/11/2015

Event Type  malfunction  

Manufacturer Narrative

Microaire was notified of this event on 09/15/2015.Due to a delay in surgery, it was determined that this event is reportable.

Event Description

On 09/15/2015, our distributor, (b)(4) reported that one of their customers experienced a problem with a power assisted lipoplasty cannula, the customer connected the cannula and the vacuum and tried to use it to suck out fat but it did not work.Upon further follow up with the end user, it was determined that surgery was delayed about 10 to 15 minutes in order to get a new cannula.

• Brand Name: MICROAIRE CANNULA
• Type of Device: TRI-PORT II CANNULA
• 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: 5128379
• MDR Text Key: 27861784
• Report Number: 2020601-2015-00092
• Device Sequence Number: 1
• Product Code: MUU
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K981922
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Report Date: 10/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: PAL-506LL
• Device Catalogue Number: PAL-506LL
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other