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 Codes	Abdominal Pain (1685); Vomiting (2144)
Date of Event	10/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The date of the sae onset was on (b)(6) 2023, but the site was aware of this event today ((b)(6) 2023), reporting this information to us this morning.The reported sae has been described as postoperative paralytic ileus with recurrent episodes of vomits after intake.Treatment with metoclopramide, ondansetron, parenteral nutrition and nasogastric tube which prolonged an existing hospitalization.The subject is a 80-year-old female patient.She presented a malignant neoplasia of the rectum, so it was decided to undergo an abdominoperineal amputation and a colostomy on (b)(6) 2023.During hospitalization, on (b)(6) 2023.She presents general malaise, headache and an episode of recurrent vomiting.The subject also showed pain on deep palpation of the hypogastrium (abdomen), with no signs of peritoneal irritation and it is noted that the ileostomy is non-functioning.She is treated with antiemetics, absolute diet and fluids.The next day, due to the lack of improvement, it was decided to place a nasogastric tube and to feed parenterally.This event was 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), 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: 17951533
• Report Number: 1223422-2023-00032
• Device Sequence Number: 6715563
• 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): 10/17/2023

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: 10/17/2023
• Initial Report FDA Received Date: 10/17/2023
• 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: 80 YR
• Patient Sex: Female