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

Catalog Number	LF1944CR
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on 11/30/2023 "the ligasure device was activated and did cut the tissue but did not coagulate like it's supposed to".Per the facility "it caused bleeding on the patient with an estimated blood loss of 200ml".Per the facility "a new ligasure was opened and used to finish procedure".Per the facility the patient "is doing ok".No additional information is available.The sample was requested for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the facility on 11/30/2023 "the ligasure device was activated and did cut the tissue but did not coagulate like it's supposed to".

• Common Device Name: LIGASURE MARYLAND 44CM FT10 COMPATIBLE
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond OR 97756
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18428084
• Report Number: 3032391-2024-00001
• Device Sequence Number: 20757457
• Product Code: NUJ
• UDI-Device Identifier: 10888277719439
• UDI-Public: 10888277719439
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: LF1944CR
• Device Lot Number: 502566
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown