MAUDE Adverse Event Report: KEY SURGICAL, LLC SKIN MARKER

Model Number	SM300
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Through follow-up with the user facility, it was disclosed that chloraprep solution was used on the patient's skin as a prep solution.The chloraprep solution contains a high percentage of isopropyl alcohol which can be used to remove the skin marker as stated in the instructions for use.The surgical skin marker instructions for use include the following language, "skin surface must be clean and dried before marking skin.Mark the desired areas on intact skin with the skin marker according to facility protocol.Allow the markings to dry thoroughly before prepping.Prepare and apply prep solution as instructed by prep solution manufacturer.Markings may fade slightly but remain legible.Remove markings with isopropyl alcohol if desired.Markings will disappear naturally with bathing in a few days." it is likely that the use of the chloraprep solution allowed the skin marker to rub off of the patient's skin.The user facility was provided with a copy of the instructions for use.The device history record was reviewed, and no abnormalities were noted.There have been no other complaints associated with this lot.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.
Event or Problem Description
The user facility reported that at the beginning of a patient procedure, it was noted that the ink from their skin marker that was used to draw on the patient prior to the procedure had rubbed off of the patient's skin.The markings had to be redrawn resulting in a procedure delay.The procedure was completed successfully.No report of injury.

• Brand Name: SKIN MARKER
• Common Device Name: SKIN MARKER
• Manufacturer (Section D): KEY SURGICAL, LLC; 8101 wallace road; eden prairie MN 55344
• Manufacturer (Section G): KEY SURGICAL, LLC; 8101 wallace road; eden prairie MN 55344
• Manufacturer Contact: coletta cohara ; 8101 wallace road; eden prairie, MN 55344 ; 4403586251
• MDR Report Key: 17602759
• Report Number: 2183785-2023-00002
• Device Sequence Number: 6263715
• Product Code: FZZ
• UDI-Device Identifier: 00849771030485
• UDI-Public: 00849771030485
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/23/2023

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: SM300
• Device Lot Number: 21040701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2021
• 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: Unknown