MAUDE Adverse Event Report: MICROLINE SURGICAL INC M/L-10 CLIP CARTRIDGE, 19 CLIPS, DISPOSABLE; LIGATION CLIP, METALLIC

Model Number	1112
Medical Device Problem Codes	Difficult to Open or Close (2921); Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During the operation, there was tissue bleeding and the tissue was clamped with the continuous titanium clip to stop the bleeding.However, the hemostatic effect was not good.It was found that the clip was not clamped tightly and did not completely close.
Additional Manufacturer Narrative
This event was submitted to microline via the fda medwatch program.The hospital that reported the event chose to stay annonymous, therefore, we can not request the device back for testing.No investigation can be done, so there are no results to report.This adverse event report is considered a combined initial/final report, and unless msi hears anything from the customer, the event will be closed.

• Brand Name: M/L-10 CLIP CARTRIDGE, 19 CLIPS, DISPOSABLE
• Common Device Name: LIGATION CLIP, METALLIC
• Manufacturer (Section D): MICROLINE SURGICAL INC; 50 dunham rd suite 1500; beverly MA 01915
• Manufacturer (Section G): MICROLINE SURGICAL INC; 50 dunham rd suite 1500; beverly MA 01915
• Manufacturer Contact: scott marchand davis ; 50 dunham rd suite 1500; beverly, MA 01915 ; 9789229810
• MDR Report Key: 22507699
• Report Number: 1223422-2025-00021
• Device Sequence Number: 18457720
• Product Code: GCJ
• UDI-Device Identifier: 00811099010432
• UDI-Public: 00811099010432
• Combination Product (Y/N): N
• PMA/510(K) Number: K013695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/15/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1112
• Device Catalogue Number: 1112
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Seven-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown