MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC. SAEED; LIGATOR, ESOPHAGEAL

Model Number	G31917
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Faulty threader blue hooks came off both ends trying to thread the string.

• Brand Name: SAEED
• Common Device Name: LIGATOR, ESOPHAGEAL
• Manufacturer (Section D): WILSON-COOK MEDICAL INC.; 4900 bethania station rd; winston salem NC 27105
• MDR Report Key: 23583996
• Report Number: 23583996
• Device Sequence Number: 18524870
• Product Code: MND
• UDI-Device Identifier: 00827002319172
• UDI-Public: (01)00827002319172(17)260808(10)W4962177
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2025
• Report Date (Section F): 10/23/2025

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: Other
• Device Model Number: G31917
• Device Catalogue Number: MBL-U-6
• Device Lot Number: W4962177
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/18/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 72 KG
• Date Report Sent to FDA: 10/23/2025