MAUDE Adverse Event Report: MENTOR TEXAS MERCEDES 2MM X 15CM SMALL HANDLE CANNULA; SYSTEM, SUCTION, LIPOPLASTY

Model Number	MER215S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2023
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.Since no lot number was provided, no manufacturing record evaluation could be performed.Reason for device explant and/or reoperation: cannula tip broke.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.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a mercedes 2mm x 15cm small handle cannula being used in a liposuction surgery broke at the tip during the operation.No adverse event was experienced by the patient and no patient consequences were reported.
Additional Manufacturer Narrative
On march 31, 2023, mentor received additional information regarding the event.It was reported that the surgeon was using the liposuction cannula on a small area of dense tissue under the breast.The tip broke off the cannula end while in the patient.The surgeon searched for and removed the tip under fluoroscopy.There was no injury to the patient.There was a delay of about 20 minutes to retrieve the broken piece.Code f1908-prolonged surgery has been added to section h6-health effect - impact code to document this additional information.The date of event was updated to march 07, 2023.The gender of the patient was updated to male.The age of the patient at the time of event was 21 years old.Manufacturer¿s reference number: (b)(4).

• Brand Name: MERCEDES 2MM X 15CM SMALL HANDLE CANNULA
• Common Device Name: 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: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 16658400
• Report Number: 1645337-2023-03787
• Device Sequence Number: 7274270
• Product Code: MUU
• UDI-Device Identifier: 00081317021407
• UDI-Public: 00081317021407
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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 Model Number: MER215S
• Device Catalogue Number: MER215S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/08/2023
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Sex: Male