MAUDE Adverse Event Report: Wilson-Cook Medical Inc Tri-Tome PC Triple Lumen Sphincterotome; Endoscopic electrosurgical unit and accessories

Model Number	G22554
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction

• Brand Name: Tri-Tome PC Triple Lumen Sphincterotome
• Common Device Name: Endoscopic electrosurgical unit and accessories
• Manufacturer (Section D): Wilson-Cook Medical Inc; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): Wilson-Cook Medical Inc; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o¿brien ; 4900 bethania station rd; winston-salem, NC 27105 ; +1(336)744-0157
• MDR Report Key: 50542614
• Report Number: 1037905-2026-00484
• Device Sequence Number: 10376607
• Product Code: KNS
• UDI-Device Identifier: 00827002225541
• UDI-Public: (01)00827002225541(17)281028(10)W4982032
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K172665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2026

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: G22554
• Device Catalogue Number: TRI-25
• Device Lot Number: W4982032
• 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: 08/05/2026
• Initial Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male