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

Model Number	1112CH
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient underwent a laparoscopic rectal resection to address an intestinal mass.During the procedure the clip malfunctioned, a nail failure occurred.The patient subsequently recovered from the adverse event.
Additional Manufacturer Narrative
The associated device has not yet been returned to microline.A full investigation will be conducted once the device is received.
Additional Manufacturer Narrative
Despite multiple requests made, the specific device associated with this complaint was not returned to msi for evaluation within 30 days.A full investigation could not be conducted.
Event or Problem Description
The patient underwent a laparoscopic rectal resection to address an intestinal mass.During the procedure the clip malfunctioned, a nail failure occurred.The patient subsequently recovered from the adverse event.

• 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 MA 01915
• Manufacturer Contact: scott marchand davis ; 50 dunham rd suite 1500; beverly, ma, MA 01915 ; 9789229810
• MDR Report Key: 23137249
• Report Number: 1223422-2025-00029
• Device Sequence Number: 8847135
• Product Code: GCJ
• UDI-Device Identifier: 00811099010432
• UDI-Public: 00811099010432
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2025

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?: No
• Device Model Number: 1112CH
• Device Catalogue Number: 1112CH
• Device Lot Number: 00175559
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 10/21/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male