MAUDE Adverse Event Report: MENTOR TEXAS PSI-TEC III ASPIRATOR, 110V; SYSTEM, SUCTION, LIPOPLASTY

Model Number	PT-ASP-III-110
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
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 manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: not applicable.(b)(4).
Event or Problem Description
It was reported that a psi-tec iii aspirator, 110v being used in an unspecified procedure was found to have suction issues (no suction pressure) during the operation.No adverse event was experienced by the patient, and there were no reported patient consequences or procedural delays.
Additional Manufacturer Narrative
On 4/29/2021, the manufacturing record evaluation (mre) of lot number 04-050108 was requested to the quality operations team.However, the physical file of the dhr was not found.Once more information is available, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).

• Brand Name: PSI-TEC III ASPIRATOR, 110V
• Common Device Name: SYSTEM, SUCTION, LIPOPLASTY
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 11713052
• Report Number: 1645337-2021-04412
• Device Sequence Number: 11825610
• Product Code: MUU
• UDI-Device Identifier: 00081317023364
• UDI-Public: 00081317023364
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K981215
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2021

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: Health Professional
• Device Model Number: PT-ASP-III-110
• Device Catalogue Number: PT-ASP-III-110
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1