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

Model Number	G22553
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During an endoscopic variceal ligation (evl) procedure in the esophagus, the physician used a cook 6 shooter saeed multi-band ligator.It was reported that during the procedure the physician wanted to place and release the first ligation band, after he placed the band on the varice the trigger cord stacked in the band and he couldn´t release the trigger cord from the band, he decided to place second band, because he thought it will help to release the first band, but it didn´t help [unable to effectively deploy bands-subject of report].He decided to stop the procedure.He didn´t want to cause any harm to nor patient or the gastroscope, so he left the trigger cord with resting 4 bands deployed in and on the gastroscope, and he decided to send it all to gastroscope producer to check it for any damage.All other resting parts of the mbl-6 were thrown away.Physician finished the procedure with new mbl-6.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.
Additional Manufacturer Narrative
Continued: section e: phone: (b)(4).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 the distal end of the endoscope in vivo, with bands entangled around the trigger cord rather than deployed on the varices.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, however, we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.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 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.

• 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: 24445887
• Report Number: 1037905-2026-00094
• Device Sequence Number: 10372873
• Product Code: MND
• UDI-Device Identifier: 00827002225534
• UDI-Public: (01)00827002225534(17)260508(10)W4937254
• Combination Product (Y/N): N
• Initial Reporter Country: DE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/25/2026

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: 05/08/2026
• Device Model Number: G22553
• Device Catalogue Number: MBL-6
• Device Lot Number: W4937254
• 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: 01/29/2026
• Initial Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2025
• 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 GIF EZ 1500
• Patient Sex: Male