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

Catalog Number	LF1937CRH
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ligasure was "sticking" during the procedure.
Additional Manufacturer Narrative
According to the facility, during a procedure the ligasure "was sticking when used at the beginning of the procedure"; the item was replaced and the procedure was completed without injury or medical intervention.During the investigation, the device was inspected and tested for nonconformities per internal procedure; clinical debris was noted in the jaws and on the handle of the device, no abnormalities were observed during the rfid data review, and simulated use was performed using beef tripe test media.Upon connection, the device was recognized by the console and no error messages appeared; during simulated use, the device sealed and cut the test media as expected, and no mechanical/functional issues were observed with the device.The reported issue was not confirmed, and the exact root cause of the reported issue could not be determined, as the reported issue could not be replicated.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: 50854165
• Report Number: 3032391-2026-00139
• Device Sequence Number: 9508606
• Product Code: NUJ
• UDI-Device Identifier: 10888277719415
• UDI-Public: 10888277719415
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 481253
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/31/2023
• 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: 01/26/2023
• 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 Age: 83 YR
• Patient Sex: Male
• Patient Weight: 198 LB