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	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The date of the sae onset was on (b)(6) 2023, but the site became aware of this event yesterday evening (26oct2023).The reported sae has been described as postsurgical hemorrhage through pelvic drainage.Decrease of hemoglobin to 7.4 g/dl.Two blood transfusions of red blood cells and administration of tranexamic acid prolonged an existing hospitalization.The subject is a 75-year-old male patient.He presented a malignant rectal neoplasia, so it was decided to undergo a robotic ultra-low anterior rectum resection, a total mesorectal excision, a manual coloanal anastomosis and a protective ileostomy.Subject underwent this surgery on (b)(6) 2023.This event initiated on the same afternoon as surgery (on (b)(6) 2023) when blood was coming out of the pelvic drainage.Bleeding was constant but the patient remained haemodynamically, so the only treatment chosen is the administration of tranexamic acid.Over the course of the hours, various blood tests were carried out, and upon observing that the haemoglobin level dropped to 7.4 g/dl, it was decided to perform 2 blood transfusions.As the days go by, the bleeding becomes less and less (tranexamic acid is still administered), the haemoglobin values recover to 10.5 g/dl and the patient has no haemodynamic symptoms.Subject has not yet been discharged from hospital, but it is expected in the next few days.This event is considered "resolved" by the site.
Additional Manufacturer Narrative
According to the investigator´s criteria, the sae has been determined to be related to the procedure (causal), but 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: 18022427
• Report Number: 1223422-2023-00035
• Device Sequence Number: 12408663
• Product Code: GEI
• UDI-Device Identifier: 00811099010388
• UDI-Public: 00811099010388
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K013695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 10/27/2023

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: 10/27/2023
• Initial Report FDA Received Date: 10/27/2023
• 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: 75 YR
• Patient Sex: Male