MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE; BIOPSY NEEDLE KIT

Model Number	G31521
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in an open pouch from the lot number provided in the report.The label matches the product returned.The first photo shows the handle end of the device and there is no stylet wire inserted in the device.The second photo shows the device inside of the tray and the handle is in the retracted position, however the needle is still advanced.The third photo provided shows the needle adjuster in the 8 position and the sheath adjuster in the 1 position.The fourth photo shows the distal end of the device, and the needle is advanced.The fifth photo shows the label, and the lot number matches that in the report.Our laboratory evaluation of the product said to be involved confirmed the report.The device returned with the needle extended out of the sheath and the handle in the advanced position; the needle adjuster was set to number 8.When the needle adjuster was changed and the handle manipulated, the needle would not advance or retract.The stylet wire was not returned with the device.The needle will not respond to handle manipulation; the needle did not seem to be moving inside the sheath or the handle.There was a pressure kink on the distal end of the needle that occurred during device manipulation.The device was disassembled for further evaluation; the device had to be soaked to remove the needle; the needle was disconnected inside of the handle; it was a clean break.When the needle was removed there were large kinks and curves throughout its length.The needle appears to have broken from excessive force during attempted needle retraction.A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed.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 laboratory evaluation of the returned device confirmed the report, the needle broke and detached inside the handle.However, 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.The instructions for use states: visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use." the instructions for use also cautions the user that, "during needle adjustment or extension, ensure device has been attached to accessory channel." attaching the needle to the endoscope will also aid in preserving the device integrity and function." prior to distribution, all echotip ultra endoscopic ultrasound 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.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 a pancreas biopsy, the physician used a cook echotip ultra endoscopic ultrasound needle.It was initially reported that after puncturing one (1) time.Penetration of the targeted site was difficult and the needle became tighter and the needle was not smooth, and the puncture was still the same.The user then took it out of the body and tried to find that it was still very tight.After that, the user replaced the ultrasound biopsy needle with a new one to continue the treatment.There was no reportable information at that time.The device was received on 01oct2025 and the needle would not retract.[subject of report] 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 ENDOSCOPIC ULTRASOUND NEEDLE
• Common Device Name: BIOPSY NEEDLE KIT
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC
• Manufacturer (Section G): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston salem NC
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston salem, NC ; 3367440157
• MDR Report Key: 23379603
• Report Number: 1037905-2025-00733
• Device Sequence Number: 8871888
• Product Code: FCG
• UDI-Device Identifier: 00827002315211
• UDI-Public: (01)00827002315211(17)280423(10)W4933058
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K171596
• 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
• Report Date (Section B): 10/24/2025

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: G31521
• Device Catalogue Number: ECHO-3-22
• Device Lot Number: W4933058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2025
• 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: OLYMPUS ULTRASOUND ENDOSCOPE WIDE-ANGLE SWEEP
• Patient Sex: Unknown