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); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Imdrf patient code e0506 captures the reportable event of hemorrhage major.
Event or Problem Description
It was reported to boston scientific corporation that an orise proknife was used in an endoscopic resection procedure performed on (b)(6) 2024.On (b)(6) 2024, the patient was admitted to the hospital with ongoing rectal bleeding.No further information has been obtained to date despite good faith efforts.
Event or Problem Description
It was reported to boston scientific corporation that an orise proknife was used in an endoscopic resection procedure performed on (b)(6) 2024.On (b)(6) 2024, the patient was admitted to the hospital with ongoing rectal bleeding.No further information has been obtained to date despite good faith efforts.***additional information received on november 7, 2024*** the patient was admitted on (b)(6) 2024, with ongoing rectal bleeding.Endoscopic submucosal dissection (esd) procedure was performed on (b)(6) 2024, to treat the bleeding in the rectum.The patient's condition after the procedure was stable.Therefore, the orise proknife was used in the procedure after the ongoing rectal bleeding.There was no adverse event related to the procedure and/or the orise proknife.It has been confirmed that this was reported in error by the account as the patient had rectal bleeding prior to the procedure with the proknife.
Additional Manufacturer Narrative
Block h11: block a2 (date of birth, age, gender, weight, ethnicity, race), b5 (event summary), and h6 (patient codes and impact codes) has been updated based on the additional information received on november 7, 2024.

• 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 CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20589735
• Report Number: 3005099803-2024-05408
• Device Sequence Number: 21068674
• Product Code: KNS
• UDI-Device Identifier: 08714729999898
• UDI-Public: 08714729999898
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Study,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

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 Expiration Date: 06/04/2026
• Device Model Number: M00519361
• Device Catalogue Number: M00519361
• Device Lot Number: 0034347821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 12/03/2024
• Date Device Manufactured: 06/04/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American