MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC SURETOME SW SPHINCTEROTOME WITH DOMETIP; ENDOSCOPIC ELECTROSURGICAL HANDPIECE/ELECTRODE, BIPOLAR, SINGLE-USE

Model Number	G61350
Medical Device Problem Codes	Accessory Incompatible (1004); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	02/03/2026
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 there was significant resistance when advancing the guide wire through the sphincterotome.This reduced ability to control the wire may have contributed to a small perforation of an intrahepatic duct.As a result, a plastic stent was placed to facilitate drainage and promote healing.Further information was received stating that the physician was using a suretome with an acrobat 2 angled 035 wire guide.They flushed the racetrack of the wire guide and the suretome lumen and loaded the wire, and some resistance with noted.They tipped the wire guide tip in water to assist.They were able to get the wire guide loaded.They accessed the duct.The user noted the wire guide felt "slippery" but they were able to maintain access.They stated that when they advanced the tome into the duct the wire traveled with it.They injected some contrast and there was a slight blushing indicative of a small intra hepatic duct perforation.They then switched wire guides to an angled 035 terumo wire guide.The physician noted resistance after the wire switch.They made multiple sweeps and placed a 10/5 plastic stent for drainage and to allow the perforation to heal.The physician stated he was not sure if it was a tome or a use issue that caused the difficulty or perforation.Patient did not require any additional procedures.A section of the device did not remain inside the patient¿s body.Per initial reporter the patient will require a second ercp to retrieve the plastic stent that was placed.There was an intrahepatic ductal perforation noted on fluoro [fluoroscopy] where the wire terminated due to this occurrence.
Additional Manufacturer Narrative
Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.Prior to distribution, all suretome sw sphincterotomes are subjected to a visual inspection and functional testing to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: based on the quality engineering risk assessment no corrective action is warranted at this time.A review of the complaint history was conducted.There have been no other similar occurrences reported during the time period reviewed.Therefore, this report represents an isolated occurrence.This product line is newly introduced and is currently undergoing a limited launch evaluation where feedback is being collected from users.The nature of the data collection and limited use is contributing to an increased rate of occurrence; therefore, no corrective action is warranted at this time.Quality assurance will continue to monitor for complaint trends.

• Brand Name: SURETOME SW SPHINCTEROTOME WITH DOMETIP
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL HANDPIECE/ELECTRODE, BIPOLAR, SINGLE-USE
• 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 ; 3367440157
• MDR Report Key: 24510162
• Report Number: 1037905-2026-00106
• Device Sequence Number: 18769304
• Product Code: KNS
• UDI-Device Identifier: 00827002613508
• UDI-Public: (01)00827002613508(17)261029(10)W4982397
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 03/03/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: G61350
• Device Catalogue Number: SUR-SW-35
• Device Lot Number: W4982397
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COOK AWG2-35-260-A WIRE GUIDE; OLYMPUS MAJ-2315 WIRE GUIDE; OLYMPUS TJF-Q190V SCOPE; TERUMO GLIDE WIRE 260
• Patient Sex: Unknown