MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC 6 SHOOTER SAEED MULTI-BAND LIGATOR; LIGATOR, ESOPHAGEAL

Model Number	G24654
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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: the information provided indicates the user intentionally deployed the bands outside of the patient.This is the most likely cause of this report.The instructions for use (ifu) states, "do not deploy bands prior to advancing endoscope to desired banding site.Deployment of bands outside of the intended banding site may not be representative of in-vivo use and will reduce the number of bands available for use." prior to distribution, all 6 shooter saeed multi-band ligators are subjected to a visual inspection 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.Additional comments regarding this report: based on the information provided that the user intentionally deployed the bands outside the patient, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.
Event or Problem Description
During setup for an unknown banding procedure, the physician selected a cook 6 shooter saeed multi-band ligator.It was reported that the bands malfunctioned, all bands are not tight.The device never made contact with patient because the doctor instructed tech to ¿test fire¿ bands outside of the patient and wasn¿t convinced the bands would hold, based on their appearance.This occurred prior to patient contact; there was no impact to the patient.In addition, the patient sustained no clinical consequence and there were no adverse effects to the patient.

• Brand Name: 6 SHOOTER SAEED MULTI-BAND LIGATOR
• Common Device Name: LIGATOR, ESOPHAGEAL
• 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: 24294657
• Report Number: 1037905-2026-00071
• Device Sequence Number: 21373785
• Product Code: MND
• UDI-Device Identifier: 00827002246546
• UDI-Public: (01)00827002246546(17)260820(10)W4965010
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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): 02/09/2026

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 Expiration Date: 08/20/2026
• Device Model Number: G24654
• Device Catalogue Number: MBL-6-OV
• Device Lot Number: W4965010
• 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: 01/15/2026
• Initial Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown