MAUDE Adverse Event Report: MICROLINE SURGICAL INC M/L-10 MULTI-FIRE CLIP APPLIER, REUSABLE; MANUAL DETACHABLE SURGICAL INSTRUMENT

Model Number	1002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Sepsis (2067)
Date of Event	03/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The subject is a 45-year-old male who underwent a right hemicolectomy due to a double adenocarcinoma of the right (stage ii) and sigmoid (stage i) colon on (b)(6) 2024.The subject had taken a second cycle of xelox (capecitabine + oxaliplatin) on (b)(6) 2024.On (b)(6) 2024 he went to the emergency room after oral intolerance, nausea, vomiting, diarrhea, and mild fever (37.5ºc).During the exploration, the physicians observed also an elevation of the acute phase reactants and hyperbilirubinemia, although an abdominal echography did not show any bladder or liver pathologic findings.The suspected diagnosis was an abdominal infection that is being treated with levofloxacin + metronidazole.As of today, the event is still considered ongoing.
Additional Manufacturer Narrative
According to the investigator´s criteria, the sae has been determined to be not related to the procedure as well as not related to the investigational device.

• Brand Name: M/L-10 MULTI-FIRE CLIP APPLIER, REUSABLE
• Common Device Name: MANUAL DETACHABLE SURGICAL INSTRUMENT
• 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: 18907252
• Report Number: 1223422-2024-00006
• Device Sequence Number: 14999820
• Product Code: GEI
• UDI-Device Identifier: 00811099010388
• UDI-Public: 00811099010388
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K013696
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/14/2024

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: 1002
• Device Catalogue Number: 1002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Seven-Day
• Initial Date Received by Manufacturer: 03/14/2024
• Initial Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male