MAUDE Adverse Event Report: WILSON-COOK MEDICAL, INC. SNAPLOC WIRE GUIDE LOCKING DEVICE; ENDOSCOPE CHANNEL ACCESSORY

Model Number	G59683
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During endoscopic retrograde cholangiopancreatography (ercp) procedures, the physician used an unknown number of cook snaploc wire guide locking devices.It was reported that the doctor noted that the wire guide was slipping and didn't feel secure with both the hydra jag 0.35 wire guide and dreamwire 0.35 wire guide.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 phone numbers: (b)(6).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 snaploc wire guide locking devices 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.Quality assurance will continue to monitor for complaint trends.

• Brand Name: SNAPLOC WIRE GUIDE LOCKING DEVICE
• Common Device Name: ENDOSCOPE CHANNEL ACCESSORY
• 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: 21721355
• Report Number: 1037905-2025-00250
• Device Sequence Number: 21216773
• Product Code: ODC
• UDI-Device Identifier: 00827002596832
• UDI-Public: (01)00827002596832(17)270808(10)W4860568
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K213483
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/28/2025

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: G59683
• Device Catalogue Number: SNAPLOC-O
• Device Lot Number: W4860568
• 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: 03/04/2025
• Initial Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2024
• 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: BOSTON SCIENTIFIC 0.35 DREAMTIME WIRE GUIDE.; BOSTON SCIENTIFIC 0.35 HYDRA JAG WIRE GUIDE.; OLYMPUS SCOPE, UNKNOWN MODEL.
• Patient Sex: Unknown