MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; MAJOR SURGICAL SETUP KIT

Catalog Number	DYNJHTSS03A
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ¿cautery pencil would not stop working even when the button was un-pressed¿.
Additional Manufacturer Narrative
The customer reported an event in the women¿s or in which the cautery pen in the major surgical set up kit would not stop working when the button was un-pressed.No sample or photo was received for investigation; finished good production records, finished good pack build, and complaint history were reviewed, with no line down situations, runs without approvals, deviations, non-conformance reports, or similar reported issues in the past 6 months.Based on the complaint details and information provided, the cautery pencil was reportedly pulled from a different source and did not come from the medline major surgical setup kit, and medline was unable to confirm the complaint issue or that the product failed to meet specifications.The cause code was adjusted to unconfirmed defect with item not in kit bom, and there was no reported death or serious injury associated with this event.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: MAJOR SURGICAL SETUP KIT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkata peruri ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50931331
• Report Number: 1417592-2026-52868
• Device Sequence Number: 16142325
• Product Code: FDE
• UDI-Device Identifier: 10888277826922
• UDI-Public: 10888277826922
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/10/2026

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: DYNJHTSS03A
• Device Lot Number: 22KBN689
• Was Device Available for Evaluation?: Yes
• 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: 03/13/2023
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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