MAUDE Adverse Event Report: MERZ NORTH AMERICA, INC. THE CELLFINA SYSTEM

Model Number CK-1 US

Device Problem Decrease in Suction (1146)

Patient Problem Laceration(s) (1946)

Event Date 03/19/2021

Event Type  Injury  

Manufacturer Narrative

The practice reported the cellfina disposable kit used during this treatment was discarded and is not available for return for evaluation.Attempts to obtain the lot number of the cellfina disposable kit used during this treatment and other pertinent information from the practice made on (b)(6) 2021, (b)(6) 2021, (b)(6) 2021, and (b)(6) 2021 have been unsuccessful.No additional information is available at this time.When additional information is received, a supplemental medwatch will be submitted.

Event Description

Merz/ulthera received information from a practice via phone call on (b)(6) 2021 regarding a cellfina adverse event.The reporter alleged that a patient treated with the cellfina system on (b)(6) 2021 sustained a laceration from the treatment which required stitches.Attempts to gather additional information from the practice on (b)(6) 2021, (b)(6) 2021, (b)(6) 2021, and (b)(6) 2021 were unsuccessful.The physician that performed this procedure phoned into merz field events on (b)(6) 2021 to provide additional information regarding the event.According to the physician, while performing treatment on this patient the cellfina disposable kit was losing vacuum and causing the blade to cut at an obtuse angle thus increasing the size of the incisions.After a couple incisions were larger than expected, the cellfina disposable kit was swapped out for a new one to complete the treatment and he confirmed the defective one was disposed of.When the procedure concluded, stitches were performed on a couple incisions to ensure proper healing.Additional information received: the patient was treated on the rear thighs on (b)(6) 2021.A follow-up appointment was scheduled with the patient; however, she contracted covid and needed to reschedule for a new appointment.He continued that the patient has not contacted him with any concerns following treatment.When more specific questions regarding treatment were asked, he deferred to his nurse and stated he would instruct her to respond to merz's previous email requests.No additional information is available at this time.

Manufacturer Narrative

The practice reported the cellfina disposable kit used during this treatment was discarded and is not available for return for evaluation.Attempts to obtain the lot number of the cellfina disposable kit used during this treatment and other pertinent information regarding the event from the practice were made on 09-apr-2021, 13-apr-2021, 28-apr-2021, and 06-may-2021.The practice did not provide any additional information.A search of the merz equipment master identified cellfina system motor module (serial number c(b)(4)) was the only motor module owned by the practice.Although it cannot be confirmed this device was used during treatment, it has been included in this investigation.An evaluation of the service history of the cellfina system motor module was not performed as cellfina devices are not serviceable equipment.An evaluation of the lot complaint history for the cellfina disposable kit associated with this event was not performed as the lot number was not provided.A review of the device history record for the cellfina system motor module identified one deviation was related to the manufacture of this device; however, this issue would not have contributed to the reported event.All required testing was passed prior to distribution.The patient investigation did not confirm a cellfina system device malfunctioned during treatment, and it is unconfirmed whether a cellfina system device caused or contributed to this event.However, medical intervention was allegedly performed on this patient to prevent permanent damage to a body structure.A contributory factor of the cellfina devices used during treatment could not be ruled out based on the information provided.This event was deemed serious following discussion with the merz product safety team.A review of the cellfina complaint trending revealed the reported issues of laceration and vacuum loss of pressure have not occurred at a high enough frequency to generate a trend and will continue to be monitored.No additional information is available at this time.If additional information is received, a supplemental report will be submitted.

• Brand Name: THE CELLFINA SYSTEM
• Type of Device: CELLFINA SYSTEM
• Manufacturer (Section D): MERZ NORTH AMERICA, INC.; 13900 w. grandview parkway; sturtevant WI 53177
• Manufacturer (Section G): MERZ NORTH AMERICA, INC.; 13900 w. grandview parkway; sturtevant WI 53177
• Manufacturer Contact: robert wdowicki ; 13900 w. grandview parkway; sturtevant, WI 53177 ; 2628353396
• MDR Report Key: 11791568
• MDR Text Key: 262198497
• Report Number: 3013840437-2021-00121
• Device Sequence Number: 1
• Product Code: OUP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192185
• 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,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CK-1 US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other