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

Model Number	M00519361
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Device was faulty and malfunctioning.

• Brand Name: ORISE¿ PROKNIFE
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 16529006
• Report Number: 16529006
• Device Sequence Number: 17454625
• Product Code: KNS
• UDI-Device Identifier: 08714729999898
• UDI-Public: (01)08714729999898(17)24042(10)29619497
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/17/2023
• Report Date (Section F): 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00519361
• Device Lot Number: 29619497
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2023
• 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
• Patient Sex: Female
• Patient Weight: 167 KG
• Date Report Sent to FDA: 02/17/2023