MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; PENCIL,CAUTERY,PUSHBUTTON,STERILE,LF,SS

Catalog Number	ESPB3000Z
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	Skin Burning Sensation (4540)
Date of Event	10/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we have had yet another burn in the or on 10/9/2023.This was a surgeon burn.No patient harm.".
Additional Manufacturer Narrative
The customer reported a burn in the or on 10/9/2023 and that this was a surgeon burn with no patient harm; according to the customer, while using the cautery pencil the surgeon felt a burning sensation on the "index finger through the glove" but "no skin burn," changed the gloves, and was able to complete the procedure.Medline quality received a sample for evaluation, and visual inspection was conducted with the provided sample; it was found that the sample was burned.At this time, the reported concern was confirmed, as the item had sign of burn, and the suspected root cause is undetermined at this time.A retrospective review of the past year for this product indicated that there have been one prior complaints in regard to this issue, and the division will continue to monitor the issue for trending.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: PENCIL,CAUTERY,PUSHBUTTON,STERILE,LF,SS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sangameswaran saravanakumar ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50818341
• Report Number: 1417592-2026-44611
• Device Sequence Number: 10218683
• Product Code: GEI
• UDI-Device Identifier: 30080196775938
• UDI-Public: 30080196775938
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 09/17/2026

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: ESPB3000Z
• Device Lot Number: 09523020027
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/20/2023
• 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: 10/11/2023
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown