MAUDE Adverse Event Report: COOK INCORPORATED TRI-TOME PC; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	G49197
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During an endoscopic retrograde cholangiopancreatography, the tri-tome sphincterotome was being used to perform a sphincterotomy (electrocautery) when the cutting wire snapped from the device.Device was immediately removed from patient.

• Brand Name: TRI-TOME PC
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 16785373
• Report Number: 16785373
• Device Sequence Number: 17501796
• Product Code: KNS
• UDI-Device Identifier: 00827002491977
• UDI-Public: (01)00827002491977(17)250930(1)
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/12/2023
• Report Date (Section F): 04/12/2023

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: G49197
• Device Catalogue Number: TRI-25M-P
• Device Lot Number: W4641555
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/21/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2023
• 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: Male
• Date Report Sent to FDA: 04/12/2023