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	10/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The date of the sae onset was on (b)(6) 2023, reporting this information to us on (b)(6) 2023 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 "bleeding in the surgical field, with hemodinamic inestability." which caused a life-threatening illness or injury.This event took place during the procedure.The subject is a 46-year-old female patient.On (b)(6) 2023 she underwent the patient underwent surgery on (b)(6) 2023 for a right distal urethral stricture.A right urethral reimplantation was performed.After the intervention, a haemorrhage was observed in the right iliac fossa.It was decided to reoperate the subject.An exploratory laparoscopy was performed.The haemorrhage was resolved after the re-intervention, so the event was considered resolved on (b)(6) 2023.
Additional Manufacturer Narrative
According to the investigator´s criteria, the sae has been determined to be related to the procedure (possible), and related to the investigational device (possible) as the possible cause is unknown.

• 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
• MDR Report Key: 18364261
• Report Number: 1223422-2023-00039
• Device Sequence Number: 20766137
• 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: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 46 YR
• Patient Sex: Female