MAUDE Adverse Event Report: Microline Surgical, Inc. M/L-10 Clip Cartridge, 19 Clips; Implantable Clip

Model Number	1112
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital found that the titanium clip was continuously clamping or unable to clamp tissue while using the device.The device was then replaced with a new one and did not cause any other impact on the patient.
Additional Manufacturer Narrative
Microline is awaiting return of the device so it can be investigated.

• Brand Name: M/L-10 Clip Cartridge, 19 Clips
• Common Device Name: Implantable Clip
• 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
• MDR Report Key: 50286267
• Report Number: 1223422-2026-00010
• Device Sequence Number: 10437296
• Product Code: GCJ
• UDI-Device Identifier: 00811099010432
• UDI-Public: 00811099010432
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K013695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2026

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
• Operator of Device: Health Professional
• Device Model Number: 1112
• Device Catalogue Number: 1112
• Device Lot Number: 00178349
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2025
• 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
• Patient Sex: Unknown