MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC FUSION TRIPLE LUMEN SPHINCTEROTOME; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	G31533
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continue e1 - phone number: (b)(6) investigation evaluation: a product evaluation was performed only by the pictures provided with this report because the products said to be involved were not provided to cook for evaluation.The lot number provided in the photos matches this report.The labeling in the photo of the device pouch matches the products reported.Our evaluation of the photos provided confirmed the report.Photos of the distal end of the devices in vivo were provided.Damage can be seen near the distal tip of the catheter with a protruding section in both photos.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: our evaluation of the photos provided confirmed the report.However, 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 fusion triple lumen 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 a total of 2 reported occurrences of this nature during the time period reviewed.Therefore, this represents an unusual occurrence.Based on this review, the likelihood of this type of report is rare.Quality assurance will continue to monitor for complaint trends.
Event or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used two cook fusion triple lumen sphincterotomes.It was reported that the sphincterotome was introduced and the physician found that the catheter distal end was split.He decided to use a second one with the same lot but it was the same problem.He used a third one with another lot and finally it was ok.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Continue e1: (b)(6).This investigation is on-going.A follow-up emdr will be provided within 30 days of receipt of new information.
Additional Manufacturer Narrative
Continue e1 - phone number: (b)(6).Investigation evaluation: the products said to be involved were returned in a biohazard bag.Two (2) of the devices (devices #1 and 2) were returned in open pouches from the lot number provided in the report.The labels match the products returned.Nine (9) additional sealed devices (devices #3-11) were returned from the lot number provided in the report.The labels match the products returned.Photos of the distal end of the devices in vivo were provided.Damage can be seen near the distal tip of the catheter with a protruding section in both photos.Device #1: our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the shaping wire removed, which was not included in the return.The cutting wire responds to handle manipulation, confirming the cutting wire remains in tact.Damage is noted along the top of the distal tip of the catheter as the wire guide lumen appears to split proximally with a slightly raised portion.When viewed from above it can be seen that the material within the wire guide lumen slightly separated and begins to curl in the lumen.Device #2: our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the shaping wire removed, which was not included in the return.The cutting wire responds to handle manipulation, confirming the cutting wire remains in tact.Damage is noted at the top of the distal tip of the catheter at the wire guide lumen with voids in the catheter material and a burr of catheter material formed at the lumen's tip.Device #3: our laboratory evaluation of the product said to be involved confirmed the report.The device was returned sealed with the shaping wire in place.A split was noted at the distal tip under magnification prior to removal of the shaping wire.No burrs or protrusions were observed.The shaping wire was removed; no additional damage was noted following the shaping wire's removal.Device #4: our laboratory evaluation of the product said to be involved confirmed the report.The device was returned sealed with the shaping wire in place.A split was noted at the distal tip under magnification prior to removal of the shaping wire with slight indentations noted at the lumen's edge.The shaping wire was removed and the split portion was noted to be raised causing a burr.When viewed from above it can be seen that the material within the wire guide lumen slightly separated and begins to curl in the lumen.Device #5: our laboratory evaluation of the product said to be involved confirmed the report.The device was returned sealed with the shaping wire in place.A slight split was noted at the distal tip under magnification prior to removal of the shaping wire.No burrs or protrusions were observed.The shaping wire was removed; no additional damage was noted following the shaping wire's removal.Device #6: our laboratory evaluation of the product said to be involved confirmed the report.The device was returned sealed with the shaping wire in place.A slight split was noted at the distal tip under magnification prior to removal of the shaping wire.No burrs or protrusions were observed.The shaping wire was removed; no additional damage was noted following the shaping wire's removal.Device #7: our laboratory evaluation of the product said to be involved could not confirm the report.The device was returned sealed with the shaping wire in place.No burrs, splits, or protrusions were observed.The shaping wire was removed; no additional damage was noted following the shaping wire's removal.Device #8: our laboratory evaluation of the product said to be involved confirmed the report.The device was returned sealed with the shaping wire in place.A split was noted at the distal tip under magnification prior to removal of the shaping wire.No burrs or protrusions were observed.The shaping wire was removed; no additional damage was noted following the shaping wire's removal.Device #9: our laboratory evaluation of the product said to be involved confirmed the report.The device was returned sealed with the shaping wire in place.Significant malformations were noted at the distal tip under magnification prior to removal of the shaping wire.Voids were noted at the tip.Burrs were observed.The shaping wire was removed; no additional damage was noted following the shaping wire's removal.When viewed from above it can be seen that the material within the wire guide lumen has split and begins to curl in the lumen.Device #10: our laboratory evaluation of the product said to be involved confirmed the report.The device was returned sealed with the shaping wire in place.A split and malformations were noted at the distal tip under magnification prior to removal of the shaping wire.Voids were noted at the tip.Slight burrs were observed.The shaping wire was removed; no additional damage was noted following the shaping wire's removal.Two (2) flecks of a black substance were noted near the distal tip.Device #11: our laboratory evaluation of the product said to be involved confirmed the report.The device was returned sealed with the shaping wire in place.A split was noted at the distal tip under magnification prior to removal of the shaping wire.No burrs or protrusions were observed.The shaping wire was removed; no additional damage was noted following the shaping wire's removal.A lab meeting was held on (b)(6) 2026, with production leadership and manufacturing engineering.During this meeting it was determined that there was evidence on multiple devices of an incomplete tip resulting in observed damage at the catheter tip.A range of damage and variability was noted at the distal tips ranging from slight splits possibly caused by where the catheter material reflows during tipping to clear malformations.The cause of the malformations on devices #1, 2, 9 and 10 is an incomplete tip formed during manufacturing in addition to failure to detect the damaged tip during the packaging process.This is considered to be an operator related nonconformance.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: our evaluation of the returned devices confirmed the report.A range of damage and variability was noted at the distal tips ranging from slight splits to clear malformations.The cause of the malformations is an incomplete tip formed during manufacturing in addition to failure to detect the damaged tip during the packaging process.This occurred due to operator error.Production management and the department team leads were notified of this occurrence.Additionally, a notification of operator related complaint form was provided to production management to make them aware of an operator related complaint.A retraining of both the operator responsible for the tipping process and the packaging operator involved has been performed.Prior to distribution, all fusion triple lumen sphincterotomes are subjected to a visual inspection and functional testing to ensure device integrity.

• Brand Name: FUSION TRIPLE LUMEN 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 ; 3367440157
• MDR Report Key: 24313677
• Report Number: 1037905-2026-00079
• Device Sequence Number: 17536023
• Product Code: KNS
• UDI-Device Identifier: 00827002315334
• UDI-Public: (01)00827002315334(17)280728(10)W4958938
• Combination Product (Y/N): N
• PMA/510(K) Number: K033203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/27/2026

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: G31533
• Device Catalogue Number: FS-25M-35
• Device Lot Number: W4958938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Supplement Date Received by Manufacturer: 02/16/2026; 03/09/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 03/16/2026; 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2025
• 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: SCOPE, UNKNOWN MAKE OR MODEL.; SCOPE, UNKNOWN MAKE OR MODEL.; TERUMO 0.035 INCH. WIRE GUIDE.; TERUMO 0.035 INCH. WIRE GUIDE.
• Patient Sex: Unknown