MAUDE Adverse Event Report: Medline ReNewal MEDLINE; LIGASURE MARYLAND 37CM FT10 COMPATIBLE

Catalog Number	LF1937CRH
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon use of the device it "would not burn.".
Additional Manufacturer Narrative
According to the customer contact, at the beginning of the procedure, the device "would not burn"; a new device was pulled with no issues, there was no injury or medical intervention reported, and the procedure was completed.The device was returned with a medline renewal package and label, but during the initial inspection, no medline renewal reprocessing marks were observed on the device, and it was observed that the device had an oem rfid paddle.No further investigation was performed, and the cause code was updated to reflect unconfirmed defect - item not purchased from medline.It was determined that the received device was oem and had not been reprocessed by medline renewal; there has been no change to the reportability decision associated with this complaint.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 37CM 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: 50872300
• Report Number: 3032391-2026-00152
• Device Sequence Number: 16124975
• Product Code: NUJ
• UDI-Device Identifier: 10888277719415
• UDI-Public: 10888277719415
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: LF1937CRH
• Device Lot Number: 485125
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/17/2023
• 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: 03/07/2023
• Initial Report FDA Received Date: 09/23/2026
• 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: Female