MAUDE Adverse Event Report: ULTHERA, INC., MERZ DEVICE INNOVATION CENTER THE CELLFINA SYSTEM

Model Number CK-1

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the reported device could not be performed as it was discarded by the facility.The cellfina disposable kit lot number associated with this event was provided, and a lot complaint history review of the device found complaint levels on this lot to be less than 1%.A device history review was performed and devices met all requirements.No non-conformance's or other issues were observed that could have contributed to the reported issue.A trend analysis of the reported issue of "blade breaks" showed no signal has occurred within the past 12 months.Attempts to obtain additional information regarding the event were performed on (b)(6) 2019; however, no additional information is available at this time.Should additional information be obtained, a supplemental report will be filed.

Event Description

A customer reported on (b)(6) 2019 that the blade in two cellfina disposable kits broke about a minute into the procedure.This is report two of two.The blade did not break while inserted into the patient and there was no injury.

• Brand Name: THE CELLFINA SYSTEM
• Type of Device: CELLFINA SYSTEM
• Manufacturer (Section D): ULTHERA, INC., MERZ DEVICE INNOVATION CENTER; 1840 south stapley drive; suite 200; mesa AZ 85204
• Manufacturer (Section G): ULTHERA, INC., MERZ DEVICE INNOVATION CENTER; 1840 south stapley drive; suite 200; mesa AZ 85204
• Manufacturer Contact: jessica ward dykstra ; 1840 south stapley drive; suite 200; mesa, AZ 85204 ; 4803361457
• MDR Report Key: 8579557
• MDR Text Key: 145648305
• Report Number: 3006560326-2019-00007
• Device Sequence Number: 1
• Product Code: OUP
• UDI-Device Identifier: 00840763100827
• UDI-Public: 00840763100827
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2019
• Device Model Number: CK-1
• Device Catalogue Number: 5036030
• Device Lot Number: 2018011204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1