MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-CHEST BREAST-LF

Catalog Number	DYNJ903638G
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the smoke evacuation rocker switch pencil did not work properly" and "the fulgteration/coag only worked intermittently.".
Additional Manufacturer Narrative
The account reported finding defective smoke evac pencil, and additional information stated that ¿the fulgteration/coag only worked intermittently.¿ a sample was received for investigation; medline received one used sample of the cautery pencil without the tip, no additional pack contents were returned, there were no visible defects, no cracks at the tip of the pencil, along the cord, or at the plug, and the buttons clicked on the pencil without sticking.As there were no defects noted with the returned sample, medline could not confirm the defect, and the vendor was unable to determine a true root cause based on the complaint information and sample availability.The vendor confirmed that the device is conforming to their design and performance specifications, and no further action was taken by the vendor at this time.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: DBD-CHEST BREAST-LF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: ankitha komirishetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50866998
• Report Number: 1417592-2026-48515
• Device Sequence Number: 9314522
• Product Code: FTN
• UDI-Device Identifier: 10198459046537
• UDI-Public: 10198459046537
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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
• Device Catalogue Number: DYNJ903638G
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/05/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown