MAUDE Adverse Event Report: Wilson-Cook Medical Inc SureTome SW Sphincterotome; Unit, electrosurgical, endoscopic (with or without accessories)

Model Number	G61351
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	06/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook suretome sw sphincterotome.It was reported that during cannulation, a perforation of the common bile duct occurred.Patient case records confirmed that the same physician had attempted an ercp on the same patient the prior monday, had significant difficulty cannulating, used a needle knife multiple times, cut into the papilla for access, and was ultimately unsuccessful.The case under investigation was therefore a redo attempt.The ercp was performed for suspected choledocholithiasis, though no stones were confirmed.The physician described a straightforward case: cannulation on the first attempt, the wire guide advancing cleanly into position in the common bile duct, contrast injection with no bowing, no rotation of the tome, and no cut performed.As he advanced the tome further into the duct with contrast still being injected, he observed bile leaking low in the common bile duct near the papilla, immediately withdrew the tome and wire guide, and aborted the procedure.He and the staff noted no defects in the device.Imaging he provided was inconclusive ¿ the fluoroscopic images did not clearly show the perforation or obvious leakage ¿ though he reported the leak was confirmed on ct.The patient was transferred to another facility, required no surgery or further intervention, and recovered uneventfully.
Additional Manufacturer Narrative
This investigation is on-going.A follow-up emdr will be provided within 30 days of receipt of new information.

• Brand Name: SureTome SW Sphincterotome
• Common Device Name: Unit, electrosurgical, endoscopic (with or without 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: 50178191
• Report Number: 1037905-2026-00392
• Device Sequence Number: 8270545
• Product Code: KNS
• UDI-Device Identifier: 00827002613515
• UDI-Public: (01)00827002613515(17)290313(10)W5015208
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K251104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2026

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: G61351
• Device Catalogue Number: SUR-SW-AWG2-35-260
• Device Lot Number: W5015208
• 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: 07/10/2026
• Supplement Date Received by Manufacturer: 08/07/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR
• Patient Sex: Unknown