MAUDE Adverse Event Report: MEDLINE RENEWAL MEDLINE RENEWAL REMANUFACTURED LIGASURE EXACT; LIGASURE EXACT DISSECTOR FT10 COMPATIBLE

Catalog Number	LF2019CRH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	10/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was used during a procedure.No issues were noted during the procedure.A few days later, the patient presented to the er with an infection, was hospitalized for 4 days, underwent a neck i&d, and was discharged on iv antibiotics.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
The device was used during a procedure.No issues were noted during the procedure.A few days later, the patient presented to the er with an infection, was hospitalized for 4 days, underwent a neck i&d, and was discharged on iv antibiotics.

• Brand Name: MEDLINE RENEWAL REMANUFACTURED LIGASURE EXACT
• Common Device Name: LIGASURE EXACT DISSECTOR FT10 COMPATIBLE
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond OR 97756
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 23706688
• Report Number: 3032391-2025-00009
• Device Sequence Number: 10670754
• Product Code: GEI
• UDI-Device Identifier: 20193489189688
• UDI-Public: 20193489189688
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Other
• Remedial Action: Other,Recall
• Type of Report: Initial
• Report Date (Section B): 12/03/2025

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 Catalogue Number: LF2019CRH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 12/03/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 66 KG