MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC ECHOTIP ULTRA FIDUCIAL NEEDLE; MARKER, RADIOGRAPHIC, IMPLANTABLE, BIOPSY NEEDLE

Model Number	G03793
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - country: hong kong.Investigation evaluation: a product evaluation was performed only by the photos and video provided in response to this report because the product said to be involved was not provided to cook for evaluation.Per the photos and video provided we cannot complete a full evaluation.Without the product or substantial evidence to contradict the complaint, it is considered confirmed based solely on statements, photos, and video describing the event.The first photo shows the distal end of the device, and the needle is slightly advanced.This is assumed to be the amount of needle that would not retract as per the customer's allegations, thus confirming the complaint.The second photo shows a small kink in the catheter, mid way along the sheath.The video shows the device, and the needle is still advanced partially, and the handle cannot pull the needle back.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 and video 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.The instructions for use (ifu) includes the following to ensure proper use of the device: "advance stylet until resistance is felt to ensure stylet is flush with proximal fiducial marker." "slowly introduce needle into accessory channel of endoscope and advance in short increments.Ensure needle is completely retracted and locked in place.Note: bends or kinks in needle caused by improper introduction may result in the inability to deploy fiducials." "with endoscope and device straight, advance needle to desired length by loosening thumbscrew on safety ring and advancing it until desired reference mark appears in window of safety ring.Tighten thumbscrew to lock safety ring in place.Note: the number in safety lock ring window indicates extension of needle in centimeters.Caution: failure to attach device prior to needle adjustment or extension may result in damage to the endoscope." "to place a fiducial, depress thumb ring while stabilizing stylet.Continue applying pressure until tactile feedback and ultrasound visualization indicates fiducial has been deployed.Fluoroscopy may also be used to aid in visualizing placement of fiducials.Note: depending on endoscope position and severity of angulation, more than one fiducial may deploy per site." prior to distribution, all echotip ultra fiducial needles 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.Quality assurance will continue to monitor for complaint trends.
Event or Problem Description
During an endoscopic ultrasonography, the physician used a cook echotip ultra fiducial needle.It was reported that the physician observed a little bit of a kink on the catheter.The nurse tried to move forward and backward try to retrieve the needle, but the handle separated into two (2), total disassembly.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: ECHOTIP ULTRA FIDUCIAL NEEDLE
• Common Device Name: MARKER, RADIOGRAPHIC, IMPLANTABLE, BIOPSY NEEDLE
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston salem, NC ; 3367440157
• MDR Report Key: 22860428
• Report Number: 1037905-2025-00605
• Device Sequence Number: 21146744
• Product Code: FCG
• UDI-Device Identifier: 00827002037939
• UDI-Public: (01)00827002037939(17)251104(10)W4885376
• Combination Product (Y/N): N
• PMA/510(K) Number: K141356
• 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): 08/21/2025

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 Expiration Date: 11/04/2025
• Device Model Number: G03793
• Device Catalogue Number: ECHO-22-F
• Device Lot Number: W4885376
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GF-UCT-260 SCOPE
• Patient Sex: Female