MAUDE Adverse Event Report: Medline ReNewal MEDLINE; LIGASURE MARYLAND 44CM FT10 COMPATIBLE

Catalog Number	LF1944CRH
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "did not burn no codes thrown.".
Additional Manufacturer Narrative
The reported issue was: "did not burn - no codes thrown"; during a "sleeve" procedure the ligasure "wouldn¿t burn," the issue was discovered at the beginning, a new ligasure was used, there was a 1 minute delay, the procedure was completed, no serious injury, medical intervention, follow-up care, or impact to the patient was reported, and the individual was reported to be "good." during the investigation, the received device was visually inspected and tested for nonconformities per internal procedure; a small amount of clinical debris was observed on the device jaws, charring was observed on the base of the jaws near the device shaft, rfid tag data showed no abnormalities or corrupt data points, and simulated use was performed on beef tripe test media with a covidien forcetriad console.The device completed the first sealing cycle successfully; upon successive sealing cycles, the activation button connection was intermittent, causing the "incomplete seal cycle" error to repeatedly appear, and the device sealed and cut as expected; however, the activation button did not operate as expected.The reported issue was confirmed; the exact root cause of the reported issue could not be determined, and a potential root cause 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 MARYLAND 44CM 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: 50854122
• Report Number: 3032391-2026-00138
• Device Sequence Number: 15865919
• Product Code: NUJ
• UDI-Device Identifier: 10888277719439
• UDI-Public: 10888277719439
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/22/2026

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: LF1944CRH
• Device Lot Number: 488711
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/17/2023
• 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: 01/24/2023
• Initial Report FDA Received Date: 09/22/2026
• 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