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

Model Number CK1-US

Device Problems Break (1069); Failure to Cut (2587)

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

Event Type  malfunction  

Manufacturer Narrative

The device is reported to be not available for investigation.No additional information is available at this time.When additional information is received, a supplemental medwatch form will be submitted.

Event Description

A physician reported to a merz practice development specialist on (b)(6) 2020 information regarding a cellfina system device malfunction.The reporter alleged that the blade of a cellfina disposable kit was not cutting well during the first two releases of a treatment; during positioning to start the third depression, the blade broke.The reporter alleged that no patient injury occured in conjunction with this event.No further information is available at this time.

Event Description

The treatment provider reported that the cellfina disposable kit used during this treatment was disposed of and the lot number of the device was not documented.Therefore, the reported cellfina disposable kit could not be requested for return.No further information is available at this time.

Manufacturer Narrative

The device was reported to be disposed of by the treatment provider and the lot number of the device was not provided.A review of the cellfina product complaint trending analysis of "blade breaks" revealed that not enough complaints have been received for this reported issue to generate a trend.A review of the cellfina product complaint trending analysis of "blade difficulty cutting" revealed that not enough complaints have been received for this reported issue to generate a trend.A review of the lot complaint history and lot history record could not be performed as the lot number of the reported cellfina disposable kit was not provided.No further information is available at this time.If additional information is received, a supplemental medwatch form will be submitted.

• 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
• MDR Report Key: 10025824
• MDR Text Key: 189896103
• Report Number: 3006560326-2020-00004
• Device Sequence Number: 1
• Product Code: OUP
• Combination Product (y/n): N
• PMA/PMN Number: K192185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CK1-US
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other