MAUDE Adverse Event Report: MICROLINE SURGICAL M/L-10 MULTI-FIRE CLIP APPLIER, REUSABLE; MANUAL DETACHABLE SURGICAL INSTRUMENTS

Model Number	1002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Chronic Obstructive Pulmonary Disease (COPD) (2237)
Date of Event	02/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject suffered from a neoplasm of the lower rectum, so an abdominoperineal robotic amputation of the rectum was performed on a prone position laparoscopically.Three robotic trocars were performed, one in the right flank, one in the left flank and one in the suprapubic area.During the surgery, the root of the inferior mesenteric artery and vein are ligated with hem-o-lock.The closure was performed at perineal level with permacol mesh and fixed with prolene stitches.The amputation lasted a total of 9 hours and was successfully performed.At the end of the surgery, a significant thoracic-facial subcutaneous emphysema was observed due to the long surgical procedure of 9 hours duration, with pneumoperitoneum leakage.The subject was admitted to the icu area intubated and since the patient had good ventilatory mechanics, with adequate gas exchange, extubation was decided the following day after ruling out the presence of pneumothorax on x-ray and a positive leak test for airway patency.The patient completed the respiratory rehabilitation program during his hospital stay without further complications.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.
Event or Problem Description
The date of the sae onset was on (b)(6) 2023, but the site was aware of this event by the end of last week (10mar2023), reporting this information to us early this morning.The reported sae has been described as subcutaneous emphysema, which led to a medical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function.

• Brand Name: M/L-10 MULTI-FIRE CLIP APPLIER, REUSABLE
• Common Device Name: MANUAL DETACHABLE SURGICAL INSTRUMENTS
• Manufacturer (Section D): MICROLINE SURGICAL; 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: 16544924
• Report Number: 1223422-2022-00018
• Device Sequence Number: 17640652
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2023

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): Five-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/15/2023
• 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): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male