MAUDE Adverse Event Report: MICROLINE SURGICAL, INC. M/L-10 CLIP CARTRIDGE, 19 CLIPS; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	1112CH
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	Intra-Abdominal Hemorrhage (4479)
Date of Event	01/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Incident reported by hospital.Microline surgical is awaiting the return of the device so that an investigation can be performed.
Event or Problem Description
During the robotic surgery in gastrointestinal ward i, it was discovered that the clip applicator and titanium clip failed to fire consecutively (not for the first time) during use.When attempting to replace the disposable titanium clip, it was found that the clip applicator and titanium clip could not be separated.The clip clamp cannot be fired in the abdominal cavity due to continuous firing.Failure to fire during surgery poses a risk of uncontrollable bleeding or damage to tissues and blood vessels.
Additional Manufacturer Narrative
Product has not been returned.No additional information can be provided.
Event or Problem Description
During the robotic surgery in gastrointestinal ward i, it was discovered that the clip applicator and titanium clip failed to fire consecutively (not for the first time) during use.When attempting to replace the disposable titanium clip, it was found that the clip applicator and titanium clip could not be separated.The clip clamp cannot be fired in the abdominal cavity due to continuous firing.Failure to fire during surgery poses a risk of uncontrollable bleeding or damage to tissues and blood vessels.

• Brand Name: M/L-10 CLIP CARTRIDGE, 19 CLIPS
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: 24223447
• Report Number: 1223422-2026-00001
• Device Sequence Number: 12811324
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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
• Operator of Device: Health Professional
• Device Model Number: 1112CH
• Device Catalogue Number: 1112CH
• Device Lot Number: 00177182
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male