MAUDE Adverse Event Report: Medline ReNewal; EICA5872-01 COBLATOR II EVAC 70 XTRA PL

Catalog Number	EICA58720RH
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2026
Type of Reportable Event	Malfunction

• Common Device Name: EICA5872-01 COBLATOR II EVAC 70 XTRA PL
• Manufacturer (Section D): Medline ReNewal; 1500 ne hemlock avenue; redmond avenue 94456 -187
• Manufacturer Contact: leann gifford ; three lakes dr; northfield, IL 60093--275
• MDR Report Key: 50132291
• Report Number: 3032391-2026-00070
• Device Sequence Number: 12171539
• Product Code: GEI
• UDI-Device Identifier: 10888277395350
• UDI-Public: 10888277395350
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2026

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: EICA58720RH
• Device Lot Number: 569582
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/04/2026
• 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): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown