MAUDE Adverse Event Report: MEDLINE RENEWAL COBLATOR II ENT EVAC 70 XTRA HP,W/INTEGRATED CABLE (BLUE/GREY); EICA5874-01 COBLATOR II,ENT EVAC 70 XT

Catalog Number	EICA58740RH
Medical Device Problem Code	Failure to Prime (1492)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported from the customer that the tonsil coblator was hooked up to the machine.When the procedure was starting, the surgeon pressed the foot pedal to prime the coblator.Fluid was not running through the tubing, so they removed the faulty coblator from the field and opened another one to finish the case.There are 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.
Event or Problem Description
It was reported from the customer that the tonsil coblator was hooked up to the machine.When the procedure was starting, the surgeon pressed the foot pedal to prime the coblator.Fluid was not running through the tubing, so they removed the faulty coblator from the field and opened another one to finish the case.

• Brand Name: COBLATOR II ENT EVAC 70 XTRA HP,W/INTEGRATED CABLE (BLUE/GREY)
• Common Device Name: EICA5874-01 COBLATOR II,ENT EVAC 70 XT
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock avenue; redmond avenue 94456 1876
• Manufacturer Contact: leann gifford ; three lakes dr; northfield, IL 60093-2753
• MDR Report Key: 25696498
• Report Number: 3032391-2026-00054
• Device Sequence Number: 9804489
• Product Code: GEI
• UDI-Device Identifier: 10888277395367
• UDI-Public: 10888277395367
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K012669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/02/2026

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: EICA58740RH
• Device Lot Number: 565641
• 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: Not provided
• Initial Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/21/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Sex: Female
• Patient Weight: 22 KG