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

Catalog Number	MBL-U-10
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2023
Type of Reportable Event	Malfunction
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.The information provided indicated that the device was used to ligate gastric fundal varices.This use is not within the intended use of the device.The instructions for use states: "this device is used to endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids." use of the device outside the intended use is likely the cause of this report.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: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.Additional comments regarding this report: based on the information provided that this device was used to ligate gastric fundal varices, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.
Event or Problem Description
During a gastric fundal variceal ligation [abnormal use], the physician used a cook 10 shooter saeed multi-band ligator.It was reported that the user successfully released 3 bands but the fourth band would not deploy.The user then forcefully pulled the trigger cord and the rest of the bands released together, and the trigger cord released from the barrel.User then changed to a domestic brand of similar device to complete the procedure.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.Our laboratory evaluation of the product said to be involved confirmed the report based on the condition of the returned device, the device was returned with four bands still on the barrel and the trigger cord broken near the connection at the barrel.A function test could not be performed due to the trigger cord being broken.A visual examination of the device was performed.The trigger cord was examined and 18 of the 20 beads were present.One of the missing beads appears as if it was there initially and the other missing bead would have been on the missing part of the trigger cord.The missing portions were not included in the return.The beads could not be verified for correct location due to the condition of the trigger cord.The beads that were present 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 was within the tolerance.The trigger cord was broken near the connection at the barrel.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 product said to be involved confirmed the report based on the condition of the returned device, the device was returned with four bands still on the barrel and the trigger cord broken near the connection at the barrel.The information provided indicated that the device was used to ligate gastric fundal varices.This use is not within the intended use of the device.The instructions for use states: "this device is used to endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids." use of the device outside the intended use is likely the cause of this report.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: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.Additional comments regarding this report: based on the information provided that this device was used to ligate gastric fundal varices, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

• Brand Name: 10 SHOOTER SAEED MULTI-BAND LIGATOR
• Common Device Name: MND, LIGATOR
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 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: 18581914
• Report Number: 1037905-2024-00047
• Device Sequence Number: 12520270
• Product Code: MND
• UDI-Device Identifier: 00827002319196
• UDI-Public: (01)00827002319196(17)231013(10)W4645703
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2024

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: 10/13/2023
• Device Catalogue Number: MBL-U-10
• Device Lot Number: W4645703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/03/2024
• Supplement Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS GIF-K240 GASTROSCOPE
• Patient Age: 89 YR
• Patient Sex: Male
• Patient Weight: 50 KG