PSI-TEC III ASPIRATOR, 110V PT-ASP-III-110

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-12-24 for PSI-TEC III ASPIRATOR, 110V PT-ASP-III-110 manufactured by Mentor Texas.

Event Text Entries

[131335693] 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 device history record review is in progress. Once completed, a supplemental report will be submitted. Manufacturer? S reference number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[131335694] It was reported that during an unspecified surgery, a strong burning scent that resembled burnt plastic began to fill the operative room. The scent was reported to have come from a mentor psi-tec iii aspirator, 110v device. The device was immediately turned off and taken out of use. After the device had been off for about 15 minutes, it was reported that the smell disappeared, indicating that the smell did come from the device. There was no procedural delay and no patient consequence.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1645337-2018-07535
MDR Report Key8194288
Report SourceUSER FACILITY
Date Received2018-12-24
Date of Report2018-11-29
Date of Event2018-11-27
Date Mfgr Received2018-11-29
Date Added to Maude2018-12-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. GABRIEL ALFAGEME
Manufacturer Street3041 SKYWAY CIRCLE NORTH
Manufacturer CityIRVING TX 75038
Manufacturer CountryUS
Manufacturer Postal75038
Manufacturer Phone949789-868
Manufacturer G1MENTOR TEXAS
Manufacturer Street3041 SKYWAY CIRCLE NORTH
Manufacturer CityIRVING TX 75038
Manufacturer CountryUS
Manufacturer Postal Code75038
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePSI-TEC III ASPIRATOR, 110V
Generic NameSYSTEM, SUCTION, LIPOPLASTY
Product CodeMUU
Date Received2018-12-24
Catalog NumberPT-ASP-III-110
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMENTOR TEXAS
Manufacturer Address3041 SKYWAY CIRCLE NORTH IRVING TX 75038 US 75038


Patients

Patient NumberTreatmentOutcomeDate
10 2018-12-24

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