MAUDE Adverse Event Report: Medline ReNewal MEDLINE; LIGASURE SMALL JAW FT10 COMPATIBLE

Catalog Number	LF1212ACRH
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "it's not firing on at all.".
Additional Manufacturer Narrative
The customer reported that the ligasure "only worked once" and "the surgeon tried to use it today and it will not work"; the failure was identified "during first attempted use" during a thyroid cystectomy, and "the patient was not affected by this during the procedure." during the investigation, the received device was visually inspected and tested for nonconformities; a small amount of clinical debris was observed on the jaws, the device otherwise passed the visual inspection with no observed issues, and the rfid tag data was captured and reviewed with no abnormalities or corrupt data points observed.Following successful connection and authentication to the covidien ft10 console, it was observed that the device would not respond when the activation button was pressed, and the reported issue was confirmed.The exact root cause of the reported issue could not be determined; a potential root cause of the reported issue was due to an internal wiring issue with the device, which prevented proper activation.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 is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: LIGASURE SMALL JAW FT10 COMPATIBLE
• Manufacturer (Section D): Medline ReNewal; 1500 ne hemlock avenue; redmond OR 94456 -187
• Manufacturer Contact: brianna montgomery ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50889592
• Report Number: 3032391-2026-00178
• Device Sequence Number: 18589805
• Product Code: NUJ
• UDI-Device Identifier: 10888277680326
• UDI-Public: 10888277680326
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: LF1212ACRH
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/27/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown