MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ORISE? PROKNIFE; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00519361
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001); Unspecified Tissue Injury (4559)
Date of Event	10/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an orise proknife was used in the rectum during a colonoscopy with endoscopic submucosal dissection (esd) on (b)(6) 2025.During the procedure, the proknife was used with standard erbe vio3 electrosurgical settings, and submucosal lifting was performed using eleview.The procedure was described as technically challenging and prolonged, lasting approximately 12 hours due to the size and complexity of the lesion.During the procedure, a suspected micro-perforation occurred, which resulted in pneumoperitoneum.The condition was managed intraoperatively with abdominal decompression.Minor bleeding was also encountered and was addressed using epinephrine and hemostatic graspers.Full-thickness closure of the site was performed using overstitch.Due to the extended duration of the procedure and elevated co2 levels, the patient remained intubated and was transferred to the intensive care unit for overnight monitoring.The following day, the physician reported that the patient was stable and was successfully extubated.The exact length of the patient's hospital stay was not reported; however, it was noted that the patient fully recovered and was discharged.
Additional Manufacturer Narrative
Block h6: imdrf patient code e2114 captures the reportable event of perforation.Imdrf patient code e0506 captures the reportable event of hemorrhage, major.Imdrf patient code e2114 captures the reportable event of pneumoperitoneum.Imdrf impact code f2301 captures the reportable event of additional device required (hemo graspers, overstitch).Imdrf impact code f0801 captures the reportable event of intensive care.Imdrf impact code f08 captures the reportable event of hospitalization.Imdrf impact code f2303 captures the reportable event of medication required (epinephrine).Imdrf impact code f23 captures the reportable event of unexpected medical intervention (abdominal decompression).

• Brand Name: ORISE? PROKNIFE
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC LIMITED; business & technology park; model farm road ; EI
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23638249
• Report Number: 3005099803-2025-06208
• Device Sequence Number: 13076138
• Product Code: KNS
• UDI-Device Identifier: 08714729999898
• UDI-Public: (01)08714729999898
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K200404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/24/2025

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: M00519361
• Device Catalogue Number: M00519361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 11/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Unknown