MAUDE Adverse Event Report: MENTOR TEXAS PSI-TECIII ASPIRATOR; SYSTEM, SUCTION, LIPOPLASTY

Model Number PT-ASP-III-110

Device Problem Failure to Power Up (1476)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/07/2022

Event Type  malfunction  

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.Since no lot number was provided, no manufacturing record evaluation could be performed.Reason for device explant and/or reoperation: not applicable.Manufacturer¿s reference number: (b)(4).

Event Description

It was reported that a 110v psi-tec iii aspirator experienced an electrical fault post procedure.At the end of surgery, the unit turned off.Different plugs and outlets were tried but it would not turn back on.No patient consequence and no adverse event was reported.

• Brand Name: PSI-TECIII ASPIRATOR
• Type of Device: SYSTEM, SUCTION, LIPOPLASTY
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: michelleann garcia ; 3041 skyway circle north; irving, TX 75038 ; 646591-798
• MDR Report Key: 14940738
• MDR Text Key: 295426925
• Report Number: 1645337-2022-07920
• Device Sequence Number: 1
• Product Code: MUU
• UDI-Device Identifier: 00081317023364
• UDI-Public: 00081317023364
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PT-ASP-III-110
• Device Catalogue Number: PT-ASP-III-110
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1