MAUDE Adverse Event Report: Wilson-Cook Medical Inc Echotip Ultra Endoscopic Ultrasound Needle; Biopsy Needle

Model Number	G31521
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2026
Type of Reportable Event	Malfunction

• Brand Name: Echotip Ultra Endoscopic Ultrasound Needle
• Common Device Name: Biopsy Needle
• 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 ; +1(336)744-0157
• MDR Report Key: 50671689
• Report Number: 1037905-2026-00516
• Device Sequence Number: 21139317
• Product Code: FCG
• UDI-Device Identifier: 00827002315211
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K171596
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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: G31521
• Device Catalogue Number: ECHO-3-22
• Device Lot Number: W4997543
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/06/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 121 LB