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

Model Number	PT-ASP-III-110
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2021
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 (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that, before an unknown procedure, a psi-tec iii aspirator, 110v was observed to have fluid in the pump.No patient consequences were reported.
Additional Manufacturer Narrative
On 26/jul/2021, mentor became aware that an expiration date was mistakenly reported in the initial report.This equipment does not have an expiration date.Manufacturer's reference number: (b)(4) in the initial report, an expiration date was provided in d4.However, this equipment does not have an expiration date.

• 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: 12181670
• Report Number: 1645337-2021-08064
• Device Sequence Number: 1622051
• Product Code: MUU
• UDI-Device Identifier: 00081317023364
• UDI-Public: 00081317023364
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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 Expiration Date: 09/22/2020
• 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: 06/23/2021
• Supplement Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 07/29/2021
• Patient Sequence Number: 1