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

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	05/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in a white plastic bag with an open box from the lot number provided in the report.The label matches the product returned.The irrigation adapter and some bands did not return with the device.Our laboratory evaluation of the product said to be involved could not confirm the report as it was described.The trigger cord was no longer attached to the barrel and the trigger cord was wrapped around the handle in a post deployment state.One loose and constricted band was returned in the box.Six loose and constricted bands were returned on the distal end of the trigger cord; the nature of how the bands were on the trigger cord suggests this did not occur during attempted deployment but were put onto the trigger cord post deployment.A visual examination of the device was performed.The trigger cord was examined and all twenty deployment beads were present.The beads were verified for correct location.The beads were examined using magnification and found to be correctly filled and had no evidence of excess flash.The trigger cord was intact and not broken.The length of the trigger cord was measured at 121.9cm between the knots which is within tolerance.An evaluation of the handle wheel movement was performed and the wheel functioned as intended.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 laboratory evaluation of the returned device could not confirm the report.A definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.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.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.
Event or Problem Description
During an endoscopic ligation procedure, the physician used a cook 10 shooter saeed multi-band ligator.It was reported that the physician used a fuji gastroscope to install a ligation device and entered the esophagus.After two bands of ligation, the third band could not be released.After removing the endoscope and reinstalling the device, it still could not be released.The endoscope body had been twisted and deformed by the trigger cord of the ligation device.Finally, the ligation device was removed from the gastroscope and the trigger cord on the ligation device was pulled, and the bands fell off completely outside the body.After replacing with another box of the same device, the remaining varicose vein ligation treatment was completed.A section of the device did not remain inside 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: 10 SHOOTER SAEED MULTI-BAND LIGATOR
• Common Device Name: LIGATOR, HEMORRHOID
• 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: 25512597
• Report Number: 1037905-2026-00281
• Device Sequence Number: 13401367
• Product Code: FHN
• UDI-Device Identifier: 00827002319196
• UDI-Public: (01)00827002319196(17)260728(10)W4958740
• 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
• Report Date (Section B): 06/15/2026

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: 07/28/2026
• Device Model Number: G31919
• Device Catalogue Number: MBL-U-10
• Device Lot Number: W4958740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 80 KG