MAUDE Adverse Event Report: KEY SURGICAL, LLC ELECTRO LUBE

Model Number	EL101
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during multiple patient procedures, purple foam pieces were noticed on instruments after using electro lube.There were reports of procedure delays as user facility personnel had to retrieve the pieces from the patients.No report of injuries.
Additional Manufacturer Narrative
Electro lube is an anti-stick phospholipid solution used on instruments to help reduce sticking during electrosurgical procedures.Electro lube is supplied with a purple sponge intended for application of the product prior to a procedure.The sponges subject of the reported events were discarded by the user facility and will be not returned to steris for evaluation.Without the return of the sponges, the cause of the reported events cannot be determined.A review of distribution records confirmed shipment of three electro lube lots to this user facility.The device history record for each of these three lots was reviewed and confirmed they were manufactured to specifications; no abnormalities were noted.A 3-year review of complaints confirms this to be isolated issue to the user facility subject of the reported event.Udi related data clarification - the lot/serial number is unknown, therefore, the applicable production identifiers were not included in the mdr.No additional issues have been reported.

• Brand Name: ELECTRO LUBE
• Common Device Name: ELECTRO LUBE
• Manufacturer (Section D): KEY SURGICAL, LLC; 8101 wallace road; eden prairie MN 55344
• Manufacturer (Section G): KEY SURGICAL, LLC; 8101 wallace road; eden prairie MN 55344
• Manufacturer Contact: coletta cohara ; 8101 wallace road; eden prairie, MN 55344 ; 4404130648
• MDR Report Key: 24642792
• Report Number: 2183785-2026-00002
• Device Sequence Number: 21305831
• Product Code: GEI
• UDI-Device Identifier: 00849771050414
• UDI-Public: (01)00849771050414
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: EL101
• Device Catalogue Number: EL101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 03/19/2026
• 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