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

Model Number	PT-ASP-III-110
Medical Device Problem Codes	Power Problem (3010); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2020
Type of Reportable Event	Malfunction
Additional 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 is in progress.Once completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a psi-tec iii aspirator, 110v has been malfunctioning outside of surgery.The physician reported that the fuses keep popping, and that the device appears to short out during usage before stopping completely.They attempted to resolve the issue by changing the fuses; however, the issue persists.No information was provided suggesting any surgical complications or procedural delays.
Additional Manufacturer Narrative
A manufacturing record evaluation was performed for the finished device number 04153207, and no non-conformance related to the reported complaint condition were identified.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The device was tested and repaired in the field by a service technician.Device evaluation summary: during the visual evaluation of the sample, minor scratches on the unit were observed.Per the service manual, operational and diagnostic analysis confirmed the unit would not start.The power entry module was replaced.Also, two non-oem screws were replaced.The testing of the device was completed per service manual.The unit has passed all functional tests and is fully operational.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Mentor received an update on the events submitted in the initial report.It was reported that the device produced a burnt rubber smell after prolonged use.In section h, updated the device code to "no code available" to reflect the burning smell.Manufacturer's reference number: (b)(4).

• Brand Name: PSI-TEC III ASPIRATOR, 110V
• Common Device Name: SYSTEM, SUCTION, LIPOPLASTY
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 9735402
• Report Number: 1645337-2020-02715
• Device Sequence Number: 2401116
• Product Code: MUU
• UDI-Device Identifier: 00081317023364
• UDI-Public: 00081317023364
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K981215
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: PT-ASP-III-110
• Device Catalogue Number: PT-ASP-III-110
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 02/21/2020; 10/22/2020; 10/22/2020
• Initial Report FDA Received Date: 02/20/2020
• Supplement Report FDA Received Date: 02/26/2020; 10/23/2020; 10/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1