MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; ELECTRODE, BLADE, 2.75, SILICONE

Catalog Number	SIL1450G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the blade is difficult to clean during procedures and reported instances of blade breakage intraoperatively.
Additional Manufacturer Narrative
It was reported that the blade is difficult to clean during procedures and reported instances of blade breakage intraoperatively.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.

• Brand Name: MEDLINE
• Common Device Name: ELECTRODE, BLADE, 2.75, SILICONE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: brooke jantzen ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25415289
• Report Number: 1417592-2026-02122
• Device Sequence Number: 9465487
• Product Code: GEI
• UDI-Device Identifier: 10193489015850
• UDI-Public: 10193489015850
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K182812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 06/05/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: SIL1450G
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown