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

Model Number	G31917
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an esophageal varices' ligation procedure, the physician used a cook 6 shooter saeed multi-band ligator.It was reported that the bands didn't function and did not hold on to the varix.4 bands deployed but none were able to ligate any varix.Other than the deployed bands, 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
Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.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: 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.Slippage of the band from the varix can occur if the endoscope is advanced beyond the banded site.The instructions for use caution the user: "passing endoscope over a previously placed band may dislodge band." 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.
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in a yellow biohazard bag with an open box and tray from the lot number provided in the report.The label matches the product returned.All components returned with the device.Our laboratory evaluation of the product said to be involved could not confirm the report of bands unable to hold on to varix but did confirm device and band deployment issues.The device returned with two bands remaining on the barrel; these bands had moved along the barrel.Additionally, on both legs of the trigger cord, the legs were no longer retained under the bands.On one leg of the trigger cord, the beads were not between the amber band and last band, but both after the last band on the barrel.The state of the bands and the trigger cord on the barrel prevented deployment of the bands onto simulated varices to test for the bands not slipping off the varices.A visual examination of the device was performed.The trigger cord was examined, and all twelve deployment beads were present on the device.The beads could not be verified for correct location as the trigger cord was still 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 on the device was measured between the knots and is within the established 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 of bands unable to hold on to varix but did confirm device and band deployment issues.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.Slippage of the band from the varix can occur if the endoscope is advanced beyond the banded site.The instructions for use caution the user: "passing endoscope over a previously placed band may dislodge band." 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.
Event or Problem Description
During an esophageal varices' ligation procedure, the physician used a cook 6 shooter saeed multi-band ligator.It was reported that the bands didn't function and did not hold on to the varix.4 bands deployed but none were able to ligate any varix.Other than the deployed bands, 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: 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: 22080431
• Report Number: 1037905-2025-00410
• Device Sequence Number: 13137029
• Product Code: MND
• UDI-Device Identifier: 00827002319172
• UDI-Public: (01)00827002319172(17)251021(10)W4880814
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: MY
• 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,Followup
• Report Date (Section B): 06/25/2025

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: 10/21/2025
• Device Model Number: G31917
• Device Catalogue Number: MBL-U-6
• Device Lot Number: W4880814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2024
• 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: GIF-HQ190 (OLYMPUS GASTRO SCOPE)
• Patient Sex: Unknown