MAUDE Adverse Event Report: MEDLINE RENEWAL COBLATOR II EVAC 70 XTRA PLASMA WAND; EICA5872-01 COBLATOR II EVAC 70 XTRA PL

Catalog Number	EICA58720RH
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that, the reprocessed coblator that half of the metal tips on the end fell off and were dangling when attempting to use on patient.Quickly removed device and opened another one and finished the case with no issues.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 medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that, the reprocessed coblator that half of the metal tips on the end fell off and were dangling when attempting to use on patient.Quickly removed device and opened another one and finished the case with no issues.

• Brand Name: COBLATOR II EVAC 70 XTRA PLASMA WAND
• Common Device Name: EICA5872-01 COBLATOR II EVAC 70 XTRA PL
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock avenue; redmond OR 94456 1876
• Manufacturer Contact: meghana maddilli ; three lakes drive; northfield, IL 60093
• MDR Report Key: 25179521
• Report Number: 3032391-2026-00010
• Device Sequence Number: 18777484
• Product Code: GEI
• UDI-Device Identifier: 10888277395350
• UDI-Public: 10888277395350
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K100543
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2026

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: EICA58720RH
• Device Lot Number: 553386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2025
• 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