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 07/28/2022

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.Reason for device explant and/or reoperation: n/a.Mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.If certain information is unknown, not available or does not apply, the section/field of the form is left blank.Manufacturer¿s reference number: (b)(4).

Event Description

It was reported that during an unspecified bladder surgery, a psi-tec iii aspirator, 110v device would not power on.It was reported that green lights turned on, but could not hear the device start up.The green lights then faded.A different outlet and a different power cord were used, but the device would still not power on.There was no reported patient consequence.

• 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 Contact: michelleann garcia ; 3041 skyway circle north; irving, TX 75038 ; 646591-798
• MDR Report Key: 15236903
• MDR Text Key: 298035802
• Report Number: 1645337-2022-09544
• 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: 08/16/2022
• 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: 07/29/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/08/2008
• 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