MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC 10 SHOOTER SAEED MULTI-BAND LIGATOR; LIGATOR, ESOPHAGEAL

Model Number	G31919
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is on-going.A follow-up emdr will be submitted within 30 days of receipt of new information.
Event or Problem Description
During an endoscopic variceal ligation procedure in the esophagus, the physician used a cook 10 shooter saeed multi-band ligator.It was reported that after 3 bands of ligation, the fourth band could not be released.Even after removing the endoscope and reinstalling it, it still could not be released [unable to deploy bands - subject of report].The endoscope body had been twisted and stretched by the trigger cord.The procedure was completed with another of the same device.Other than the deployed bands, 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.
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in a white plastic bag with an open box and tray from the lot number provided in the report.The label matches the product returned.The irrigation adapter and 5 bands were not returned.Our laboratory evaluation of the product said to be involved confirmed the report based on the condition of the returned device.A visual inspection showed that five bands remained on the barrel, two of the black bands had moved slightly along the barrel, and a portion of the trigger cord had come away from the barrel and was no longer properly retained under the bands.Eighteen of the twenty deployment beads are present on the trigger cord; two are missing, most likely having come off during the difficult deployment attempts.Correct bead placement could not be verified due to the trigger cord still being attached to the barrel.The beads were examined using magnification and found to be correctly filled and had no evidence of excess flash.The length of the trigger cord was measured between the knots and is within the established tolerance.The trigger cord was intact and not broken.A function test was not performed to deploy the remaining band due to the condition of the returned device.The subassembly history record for the trigger cord said to be involved was reviewed.The quality control tensile test performed on a sample of the manufactured units met the acceptance criteria.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.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 returned device confirmed the report.However, a definitive cause for the reported observation could not be determined because the condition of the product said to be involved prohibited a complete evaluation.Bands had moved along the barrel, the trigger cord was no longer properly retained under the bands, and two deployment beads were missing.Band deployment difficulty can occur if the endoscope accessory channel is compromised.In these cases, the endoscope accessory channel collapses, restricting the trigger cord and preventing proper band deployment.In these cases the endoscope may torque when deployment is attempted.The instructions for use contain the following statement: "use of an endoscope in a sound state of repair is a prerequisite for a successful multi-band ligation procedure." band deployment difficulty can also occur if the trigger cord is not properly seated in the handle assembly.The instructions for use advise the user: "note: knot must be seated into hole or handle will not function properly." a precaution in the instructions for use state: "it is vital that the integrity of the working channel is intact as grooves or other obstructions in the working channel can potentially cause the string to catch, resulting in band deployment difficulty." it is possible that this could lead to band deployment difficulty and damage to the trigger cord as well.Prior to distribution, all 10 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: a cook representative has been directed to contact the medical facility involved and inform them of the missing deployment beads on the trigger cord that was discovered during the evaluation of the returned device.

• Brand Name: 10 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: 23924122
• Report Number: 1037905-2025-00873
• Device Sequence Number: 21120261
• Product Code: MND
• UDI-Device Identifier: 00827002319196
• UDI-Public: (01)00827002319196(17)260522(10)W4941957
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2026

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: 05/22/2026
• Device Model Number: G31919
• Device Catalogue Number: MBL-U-10
• Device Lot Number: W4941957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2025
• Supplement Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2025
• 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: OLYMPUS GASTROSCOPE-UNKNOWN MODEL
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 50 KG