MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; ELECTRODE,BLADE,2.75,SILICONE, INSULATED

Catalog Number	SIL1455
Medical Device Problem Codes	Crack (1135); Melted (1385); Material Puncture/Hole (1504)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the side of electrode melted and exposed a hole in the insulation and noticed a small crack leading to the base of the tip.The location of the tip that failed: ¿right above the dark blue part of plastic¿.
Additional Manufacturer Narrative
The customer reported that the item was being used when a patient burn occurred, and the side of electrode melted and exposed a hole in the insulation and noticed a small crack leading to the base of the tip; according to the facility, "the patient experienced a burn on the outside of her breast" while using a cautery blade.Medline quality received samples for evaluation, and visual and functional inspection was conducted; visual inspection of the provided defective sample found that the side of the electrode did show signs of melting and a crack was observed at the base of the tip.The reported concern was confirmed, as the sample showed signs of being defective.The suspected root cause is undetermined at this time; the division will continue to monitor this 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: ELECTRODE,BLADE,2.75,SILICONE, INSULATED
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50883283
• Report Number: 1417592-2026-49807
• Device Sequence Number: 9939327
• Product Code: GEI
• UDI-Device Identifier: 20193489015895
• UDI-Public: 20193489015895
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K182812
• 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): 09/23/2026

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: SIL1455
• Device Lot Number: 2023012790
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/07/2023
• 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: 03/21/2023
• Initial Report FDA Received Date: 09/24/2026
• 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