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	Vomiting (2144); Pneumoperitoneum (4819)
Date of Event	10/08/2023
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 (18oct2023), reporting this information to us this morning.The reported sae has been described as large postsurgical pneumoperitoneum, subcutaneous emphysema and bilateral pleural effusion observed in imaging test suspicious of gastrointestinal perforation which prolonged an existing hospitalization.The subject is a 85-year-old male patient.He presented a sigmoid neoplasia, so it was decided to undergo a robotic sigmoidectomy on (b)(6) 2023.During hospitalization, on (b)(6) 2023, the subject was evaluated after being notified by the radiology team due to the presence of pneumoperitoneum in ct performed at the request of the vascular surgery service due to the suspicion of ischemia of the lmii.The tc image showed a large postsurgical pneumoperitoneum, subcutaneous emphysema, and bilateral pleural effusion suspicious of gastrointestinal perforation.No signs of anastomotic dehiscence.It was decided to treat the subject with parenteral nutrition, omeprazole, and antibiotics.The subject was discharged from the hospital on (b)(6) 2023, but was readmitted to the hospital on (b)(6) 2023 due to fever and vomits.New imaging test shows the persistence of voluminous pneumoperitoneum suspicious of high gastrointestinal perforation.This event is still ongoing.
Additional Manufacturer Narrative
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.

• 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: 17957241
• Report Number: 1223422-2023-00033
• Device Sequence Number: 17922101
• 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): 10/18/2023

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: 10/18/2023
• Initial Report FDA Received Date: 10/18/2023
• 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: 85 YR
• Patient Sex: Male