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

Model Number	G31917
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: a product evaluation was performed only by the picture provided in response to this report because the product said to be involved was not provided to cook for evaluation.Per the photo provided we cannot complete a full evaluation.Without the product or substantial evidence to contradict the complaint, it is considered confirmed based solely on statements and photo describing the event.The photo shows 4 bands on a table surface outside of the body, and 3 of the 4 bands are not constricted.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 evaluation of the photo provided confirmed the report.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 (b)(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: based on the information provided that the user intentionally deployed the bands outside of 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
In preparation for an esophagogastroduodenoscopy with banding, the physician selected four cook 6 shooter saeed multi-band ligators.It was reported that prior to use the physician always fires off one band, the bands are not the size they should be when coming off the barrel.They appear to be bigger than normal.In the picture [provided for evaluation], the small band came from [the device] that was used to complete the procedure.All four devices were used in the same procedure and the devices were discarded after the initial band was fired off before making patient contact.This occurred prior to patient contact; there was no impact to the patient.In addition, the user sustained no clinical consequence and there were no adverse effects to the user.

• 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: 24717882
• Report Number: 1037905-2026-00147
• Device Sequence Number: 6121756
• Product Code: MND
• UDI-Device Identifier: 00827002319172
• UDI-Public: (01)00827002319172(17)260818(10)W4964258
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 03/27/2026

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: 08/18/2026
• Device Model Number: G31917
• Device Catalogue Number: MBL-U-6
• Device Lot Number: W4964258
• 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: 03/02/2025
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2025
• 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: SCOPE, UNKNOWN MAKE OR MODEL
• Patient Sex: Unknown