MAUDE Adverse Event Report: MENTOR TEXAS PSI-TEC III ASPIRATOR, 110V; 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 04/27/2022

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.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 Description

It was reported that a psi-tec iii aspirator, 110v device powered off during an unspecified surgery.It was discovered that a 15a 125v gma fuse had blown.The fuse was replaced but the device would not power on.It was reported that there was no fluid invasion.No patient consequence was reported.

• Brand Name: PSI-TEC III ASPIRATOR, 110V
• 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: 14459572
• MDR Text Key: 292205770
• Report Number: 1645337-2022-05899
• Device Sequence Number: 1
• Product Code: MUU
• UDI-Device Identifier: 00081317023364
• UDI-Public: 00081317023364
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981215
• 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: 05/20/2022
• 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: 04/29/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/24/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1