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

Model Number PT-ASP-III-110

Device Problem Failure to Power Up (1476)

Patient Problem Insufficient Information (4580)

Event Date 12/08/2021

Event Type  Injury  

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.Reason for device explant and/or reoperation: n/a.Manufacturer¿s reference number: (b)(4).

Event Description

It was reported that a psi-teciii aspirator 110v, stnd completely shut down and had no power intra-operatively.It was indicated that this incident caused injury to the patient.Follow-ups were performed but no additional information was made available.

• Brand Name: PSI-TECIII ASPIRATOR 110V, STND
• 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: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 9497898687
• MDR Report Key: 13183549
• MDR Text Key: 284146964
• Report Number: 1645337-2022-00213
• 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
• Report Date: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: Yes
• 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: 12/08/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/10/2006
• 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
• Patient Outcome(s): Other