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	Retroperitoneal Hemorrhage (4483)
Date of Event	05/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The reported sae has been described as rectorraghia: rectal bleeding after rectoscopy which led to in-patient hospitalization.The subject is a 71-year-old male patient.This patient underwent an laparoscopic ultra-low anterior rectum resection due to a neoplasm in the rectum that was found during a ct scan (this subject suffers from metastatic castration-resistant adenocarcinoma of the prostate.He has been undergoing treatment for years).This rectal tumor was confirmed after a colonoscopy performed on (b)(6) 2023.Thus, it was decided to perform a protective ileostomy.The subject was operated on (b)(6) 2023.On (b)(6) 2023, the patient attended a check-up with the surgeon and underwent a rectoscopy with an opaque enema to assess the surgical closure of the stoma.During the rectoscopy, bleeding occurred without major incidents, but continued for several days until (b)(6) 2023 when he went to the emergency department and was hospitalized for observation and colonoscopy.
Additional Manufacturer Narrative
We can say that this second episode of rectorrhagia is caused by the rectoscopy, so it could be considered a separate episode although the adverse event is the same.According to the investigator´s criteria, the sae has been determined not related to the procedure, nor 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
• Manufacturer Contact: scott marchand davis ; 50 dunham rd suite 1500; beverly, MA 01915 ; 9789229810
• MDR Report Key: 17166889
• Report Number: 1223422-2023-00022
• Device Sequence Number: 12117901
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/26/2023

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: 05/23/2023
• Initial Report FDA Received Date: 06/20/2023
• 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: 71 YR
• Patient Sex: Male