MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC 4 SHOOTER SAEED MULTI-BAND LIGATOR; LIGATOR, ESOPHAGEAL

Model Number	G31915
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
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 indicated that the device was used to ligate stomach varices.This use is not within the intended use of the device.The instructions for use states: "this device is used to endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids." use of the device outside the intended use is likely the cause of this report.Prior to distribution, all 4 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: the information provided indicated that the device was used to ligate stomach varices.This use is not within the intended use of the device.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 an esophagogastroduodenoscopy (egd) procedure with stomach varices banding, the physician used a cook 4 shooter saeed multi-band ligator.It was reported that the physician attempted to fire the band and no bands would deploy.The ligator was removed and the procedure completed with another of the same device with no further complications.A section of the device did not remain in 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: 4 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: 22422202
• Report Number: 1037905-2025-00501
• Device Sequence Number: 6979561
• Product Code: MND
• UDI-Device Identifier: 00827002319158
• UDI-Public: (01)00827002319158(17)251219(10)W4899072
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/07/2025

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: 12/19/2025
• Device Model Number: G31915
• Device Catalogue Number: MBL-U-4
• Device Lot Number: W4899072
• 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: 06/12/2025
• Initial Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2024
• 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: ENDOSCOPE-OLYMPUS GIF H190
• Patient Sex: Unknown