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

Model Number	1112CH
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was locked down, and could not be removed.It was replaced it with a new product.
Event or Problem Description
The product was locked down, can't be removed.Replaced it with a new product.
Additional Manufacturer Narrative
The associated product was not returned to msi for investigation.
Event or Problem Description
The product was locked down, can't be removed.Replaced it with a new product.

• Brand Name: M/L-10 CLIP CARTRIDGE, 19 CLIPS, DISPOSABLE
• Common Device Name: LIGATION CLIP, METALLIC,
• Manufacturer (Section D): MICROLINE SURGICAL; 50 dunham rd; suite 1500; beverly MA 01915
• Manufacturer (Section G): MICROLINE SURGICAL; 50 dunham rd; suite 1500; beverly
• Manufacturer Contact: scott marchand davis ; 50 dunham rd suite 1500; beverly, ma, MA
• MDR Report Key: 22743229
• Report Number: 1223422-2025-00025
• Device Sequence Number: 18247510
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

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 Model Number: 1112CH
• Device Catalogue Number: 1112CH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown