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

Model Number	G22553
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
In preparation for an unknown endoscopic procedure in the stomach, the physician selected a 6 shooter saeed multi-band ligator.It was reported that during installation, the wire [trigger cord] was being tensioned while winding, but the blue hook broke and the device became unusable.A photo was provided of the loading catheter with missing blue hooks.The procedure was completed with another of the same device.This occurred prior to patient contact; there was no impact to the patient.In addition, the patient sustained no clinical consequence and there were no adverse effects to the patient.
Additional Manufacturer Narrative
Continued: section e phone: (b)(6).Investigation evaluation: the product said to be involved was returned in a clear plastic bag with an open box and tray from the lot number provided in the report.The label matches the product returned.Only the handle, loading catheter without hooks, irrigation adapter, and barrel without bands returned.A photo was provided and reviewed.The photo shows the loading catheter and both blue hooks are missing.Our laboratory evaluation of the product said to be involved confirmed the report.Both hooks were completely detached from the loading catheter and were not returned.A dimensional inspection was performed on the loading catheter.The inner diameter was measured within the specification.A product specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.The subassembly history record for the loading catheter said to be involved was reviewed.The quality control tensile test performed on a sample of the manufactured units met the acceptance criteria.A discrepancy or anomaly was not observed with the product that was released for distribution.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: a visual examination of the returned product identified the blue hooks were completely detached from both ends of the loading catheter and did not return.A definitive cause for this observation could not be determined because the set up conditions could not be duplicated in the laboratory setting.This limits our ability to conclusively determine a cause.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.The blue hook can detach if it gets caught in the accessory channel of the endoscope.The instructions for use advise the user: "it is vital that the integrity of the working channel is intact." prior to distribution, all 6 shooter saeed multi-band ligators are subjected to a visual inspection to ensure device integrity.All loading catheters that are included in the multi-band ligators are subjected to a visual inspection and functional testing 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 Manufacturer Narrative
As of 09/12/2025, future reports of this nature will cease to be reported to the fda.There have been zero serious injuries and zero deaths for the related malfunctions in the past 3 years.Please reference fda document number (b)(4).

• 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: 22938129
• Report Number: 1037905-2025-00633
• Device Sequence Number: 21298313
• Product Code: MND
• UDI-Device Identifier: 00827002225534
• UDI-Public: (01)00827002225534(17)260109(10)W4903629
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 09/02/2025

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: 01/09/2026
• Device Model Number: G22553
• Device Catalogue Number: MBL-6
• Device Lot Number: W4903629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2025
• 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: ENDOSCOPE OLYMPUS H260.
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 66 KG