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

Catalog Number PT-ASP-III-110

Device Problems Break (1069); Failure to Power Up (1476)

Patient Problem No Patient Involvement (2645)

Event Date 03/15/2019

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.A manufacturing record evaluation (mre) is in progress.Once completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).

Event Description

It was reported that as the facility went to turn a psi-tec iii aspirator 110v pump on, there was a spark and no power.The power button was also reported to be broken.The problem occurred before surgery and there was no patient involvement.

Manufacturer Narrative

In the intial report 1645337-2019-10269 submitted on 4/15/2019 it was stated that an mre was in progress.However, no lot number was provided for this device.Since no lot number was provided, no manufacturing record evaluation could be performed.Manufacturer¿s reference number: (b)(4).

• Brand Name: PSI-TECIII ASPIRATOR 110V
• Type of Device: SYSTEM, SUCTION, LIPOPLASTY
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8515842
• MDR Text Key: 141983743
• Report Number: 1645337-2019-10269
• Device Sequence Number: 1
• Product Code: MUU
• UDI-Device Identifier: 00081317023364
• UDI-Public: 00081317023364
• Combination Product (y/n): N
• PMA/PMN Number: K981215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PT-ASP-III-110
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/16/2019
• Patient Sequence Number: 1