MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC (COOK ENDOSCOPY) D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	G25790
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continued: e1 - phone number: (b)(6).The investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report.
Event or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook d.A.S.H.Dometip double lumen sphincterotome.It was reported that the wire guide coating peeled off during the case.Photo of device showing the wire guide coating damage was provided.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
Continued: e1 - phone number: (b)(6).Investigation evaluation: the product said to be involved was returned in an open tray from the lot number provided in the report.The label matches the product returned.In the photo provided the device is pictured with the coating damaged and the core wire exposed.Our evaluation of the product said to be involved confirmed the report.The metii-21-480 wire guide was returned still advanced into the dash sphincterotome.The distal end of the wire guide was advanced out of the distal end of the sphincterotome 4.6cm.When removed from the sphincterotome the coating has stripped, exposing the distal coil spring and core wire, from the distal tip to 7.9cm from the distal tip.Within the clear catheter it can be seen that the coating has bunched and peeled from the wire guide, remaining within the clear catheter, and is surrounded by an unknown white substance which is present throughout the distal catheter.The white substance was also noted on the coil spring of the wire guide.The pieces peeling from the wire guide seem to have been degraded and crumble when handled.A bend was noted in the core wire 3.2cm from the distal tip.The distal weld bead remains intact on the coil spring, indicating no portion has detached.Due to the significant amount of coating retained within the clear catheter, it is believed that no portion is missing.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 product said to be involved, and the photo provided, confirmed the report of coating damage.A definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.If additional pressure is applied to the wire guide and/or accessory device(s) while moving the wire guide inside the accessory device(s), this could contribute to wire guide coating damage.Prior to distribution, all d.A.S.H.Dometip double lumen sphincterotomes are subjected to a visual inspection to ensure device integrity.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.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 a cook d.A.S.H.Dometip double lumen sphincterotome.It was reported that the wire guide coating peeled off during the case.Photo of device showing the wire guide coating damage was provided.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.

• Brand Name: D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME
• Common Device Name: UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): WILSON-COOK MEDICAL INC (COOK ENDOSCOPY); 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): WILSON-COOK MEDICAL INC (COOK ENDOSCOPY); 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: 21576227
• Report Number: 1037905-2025-00202
• Device Sequence Number: 8271825
• Product Code: KNS
• UDI-Device Identifier: 00827002257900
• UDI-Public: (01)00827002257900(17)270430(10)W4833076
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2025

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: G25790
• Device Catalogue Number: DASH-21-480
• Device Lot Number: W4833076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2024
• 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.
• Patient Sex: Unknown