MAUDE Adverse Event Report: MENTOR TEXAS ACCELERATOR II, ASPIRATOR (110V); SYSTEM, SUCTION, LIPOPLASTY

Catalog Number	ASP II
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.A device history record review is in progress.Once completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that during a fat grafting procedure performed with an accelerator ii aspirator, fluid was sucked into the generator.Per customer, there was no injury to the patient or the user of the device.
Additional Manufacturer Narrative
On 3/3/2018, the mentor failure analysis lab received the device for evaluation.The analysis has begun, but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
During failure analysis, it was determined that the device returned under this complaint file was not the complaint device.The complaint device for this report still has not been received.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
The device history record (dhr) was reviewed, and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer¿s reference number: (b)(4).

• Brand Name: ACCELERATOR II, ASPIRATOR (110V)
• Common Device Name: SYSTEM, SUCTION, LIPOPLASTY
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 7261568
• Report Number: 1645337-2018-00806
• Device Sequence Number: 1036459
• Product Code: MUU
• UDI-Device Identifier: 00081317020028
• UDI-Public: 00081317020028
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/11/2018

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: Health Professional
• Device Catalogue Number: ASP II
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2018
• Initial Date Received by Manufacturer: 01/11/2018
• Supplement Date Received by Manufacturer: 01/11/2018; 01/11/2018; 08/11/2018
• Initial Report FDA Received Date: 02/09/2018
• Supplement Report FDA Received Date: 03/29/2018; 07/25/2018; 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1