MAUDE Adverse Event Report: MICROLINE SURGICAL INC M/L-10 MULTI-FIRE CLIP APPLIER, REUSABLE; OPEN-SURGERY LIGATION CLIP APPLIER

Model Number	1002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Hepatic or Biliary Problem (4493)
Date of Event	04/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event occured during a clinical study in which the m/l-10 multi-fire clip applier was used (as part of the study).However, according to the investigator´s criteria, the sae has been determined to be not related to the procedure, not related to the investigational device, and not related to leakage, by the hospital team.This cholecystitis was then treated and resolved on (b)(6) 2023 with a cholecystectomy.There is no evidence of the device in question causing the adverse event.
Event or Problem Description
The sae was described as a "chronic lithiasis cholecystitis (with marked epithelial denudation)" and its onset date was (b)(6) 2023.The subject is a 60-year-old male who underwent a laparoscopic cholecystectomy (general surgery), placing 6 clips in blood vessels and the bile duct, on (b)(6) 2023.On (b)(6) 2023, during the 30-day follow-up visit of the study, the subject manifested pain and discomfort due to the accumulation of gallstones because of the previously diagnosed pathology (chronic lithiasis cholecystitis), after being confirmed by an abdominal ultrasound.The subject was then programmed for the surgical removal of the gallbladder on (b)(6) 2023.According to the investigator´s criteria, the sae has been determined to be not related to the procedure, not related to the investigational device, and not related to leakage, by the hospital team.This cholecystitis was then treated and resolved on (b)(6) 2023 with a cholecystectomy.

• Brand Name: M/L-10 MULTI-FIRE CLIP APPLIER, REUSABLE
• Common Device Name: OPEN-SURGERY LIGATION CLIP APPLIER
• 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: 20348699
• Report Number: 1223422-2024-00033
• Device Sequence Number: 12768460
• Product Code: GCJ
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2024

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): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 10/01/2024
• 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: 60 YR
• Patient Sex: Male