MAUDE Adverse Event Report: MENTOR TEXAS CANDYCANE 4MM 26CM LG; SYSTEM, SUCTION, LIPOPLASTY

Model Number	CCC426L
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a cannula bent during breast lift and axilla lipo.The device was a candycane 4mm 26cm lg large handle cannula on which the canula bent during surgery.The canula was bent at the neck of handle and tip.There was no patient involvement.
Additional Manufacturer Narrative
The mentor failure analysis lab has received the device for evaluation.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.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: bent tip manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Devices' photo evaluation completed on march 24, 2022: upon visual evaluation of the image provided in the complaint, the cannula was observed bent.As the product involved in this complaint was discarded, the device couldn´t be analyzed according to our procedures.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Manufacturer¿s reference number: (b)(4).Initial report mistakenly reported that the device was received.Correction: device image was received.

• Brand Name: CANDYCANE 4MM 26CM LG
• 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: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 9497898687
• MDR Report Key: 13870201
• Report Number: 1645337-2022-03157
• Device Sequence Number: 14625723
• Product Code: MUU
• UDI-Device Identifier: 00081317020899
• UDI-Public: 00081317020899
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,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: CCC426L
• Device Catalogue Number: CCC426L
• Device Lot Number: 18110703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 03/24/2022; 04/11/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 03/25/2022; 04/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2018
• 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 Sex: Female