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

Model Number	1002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Gastrointestinal Hemorrhage (4476)
Date of Event	11/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the investigator´s criteria, the sae has been determined to be not related to the procedure (probable), nor to the investigational device.
Event or Problem Description
The date of the sae onset was on 1nov2023, reporting this information to us on 15dec2023 during the evening.During this time we have been requesting additional information from the site as the information provided in the edc castor was insufficient.The reported sae has been described as self-limiting rectorrhagia which prolonged an existing hospitalization.The subject is a 83-year-old female patient.On (b)(6) 2023 she underwent a dorsoventral right hemicolectomy due to a neoformation of the cecum.Postoperative period was favorable and she was discharged home on (b)(6) 2023.On (b)(6) 2023 she returned to the emergency department due to a stool with fresh blood.She reported no abdominal pain nor haemodynamic instability.A diagnosis of rectorrhagia was made.It was decided to suspend the anticoagulant treatment, and start a serum therapy treatment, intravenous analgesia and fasting.The incident was resolved with medication and she was discharged on (b)(6) 2023.The event was considered resolved on 2nov2023.

• Brand Name: M/L-10 MULTI-FIRE CLIP APPLIER
• 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
• MDR Report Key: 18364247
• Report Number: 1223422-2023-00038
• Device Sequence Number: 7730768
• 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): 12/19/2023

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: 12/19/2023
• Initial Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization
• Patient Age: 83 YR
• Patient Sex: Female