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

Catalog Number	LF1937CRH
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "during surgery the device failed in the way of the instrument jaw separating from the housing during use.".
Additional Manufacturer Narrative
The customer reported that during surgery a ligasure maryland jaw laparoscopic device failed in the way of the instrument jaw separating from the housing during use.During the investigation, the received device was inspected and tested for nonconformities per internal procedure; clinical debris was observed on the jaws and handle of the device, and the jaw had separated from the device.Reported issue confirmed was documented as n/a - oem, and the exact root cause of the reported issue could not be determined.Due to the device having an oem paddle, oem packaging, and oem lot number, and no observable medline renewal reprocessing marks, it was determined that the received device was oem and had not been reprocessed by medline renewal.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: 50854105
• Report Number: 3032391-2026-00137
• Device Sequence Number: 9553926
• Product Code: NUJ
• UDI-Device Identifier: 10888277719415
• UDI-Public: 10888277719415
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/27/2023
• 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: 01/19/2023
• 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