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	Impaired Healing (2378)
Date of Event	02/14/2024
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 neither the procedure or the device.
Event or Problem Description
The sae onset was on (b)(6) 2024 but the site became aware of the event on 13jun2024.The sae has been described as "perineal wound dehiscence".The subject is a 78-year-old who underwent a cholecystectomy on (b)(6) 2024.On (b)(6) 2024 the subject suffered a dehiscence of the surgical wound that presented good appearance, it was dry and without suppuration.She was intervened by the friederich technique on 17feb2024 and was then discharged on (b)(6) 2024.According to the investigator´s criteria, the sae has been determined to be not related to neither the procedure or the 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; 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: 19538985
• Report Number: 1223422-2024-00022
• Device Sequence Number: 6030967
• 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): 06/14/2024

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): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 06/14/2024
• 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; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Female