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

Catalog Number	LF1937CRH
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "device not recognized by bovie.Was inserted into trocar and attempted to use on patient without success.".
Additional Manufacturer Narrative
The reported issue was that the device was not recognized by bovie and was inserted into trocar and attempted to use on patient without success; no medical intervention, adverse patient consequence, general anesthesia, or injuries were reported.During the investigation, the received device was inspected and tested for nonconformities per internal procedure; clinical debris was observed on the jaws of the device, however, no abnormalities were observed, and the received device¿s rfid tag data was captured and reviewed using the medline renewal ligasure rfid scanner engineering application.Upon review of the rfid tag data, it was confirmed that the device had been previously connected to a covidien ft10 console; however, no abnormalities or corrupt data points were observed, the rfid tag was able to be renewed successfully, and the reported issue was confirmed.The root cause of the e420 usage limit error message is due to what medline perceives as anti-reprocessing technology/encryptions inside the covidien ft10 console, which in rare cases may "block" medline renewal reprocessed ligasure devices from being authenticated; this is not a failure of a reprocessed product¿s performance and does not identify any faults or failures with the ligasure product.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: 50805179
• Report Number: 3032391-2026-00110
• Device Sequence Number: 10611080
• Product Code: NUJ
• UDI-Device Identifier: 10888277719415
• UDI-Public: 10888277719415
• 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): 09/17/2026

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: 486930
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/08/2023
• 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: 07/13/2023
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (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: 45 YR
• Patient Sex: Female