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

Catalog Number	MBL-6-XS
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Gastrointestinal Hemorrhage (4476)
Date of Event	12/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During an esophageal variceal ligation in a pediatric digestive functional exploration service, the physician used two cook 6 shooter saeed multi-band ligators.It was reported that after a first successful ligature, the elastic used on a second varice was sucked up by the endoscope.The issue occurred 3 times in spite of a change of lot number and endoscope operator (other lot affected - captured in a separate report).Although the instructions for use do not explicitly state that the device cannot be used on a pediatric patient, these devices should only be used with adult patients as they were not tested on pediatric populations nor were they approved for pediatric use.These trials extended the procedure by an hour under general aesthesia.Patient injured nose throat because the device was introduced through the nose.Important bleeding.Night in intensive care unit.Pack of blood & platelets.Further information is requested.
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 user inserted the endoscope/ligation device down a patient's nose.This use is not within the intended use of the device.The instructions for use states: "those specific to primary endoscopic procedure to be performed in gaining access to desired banding site." the instructions for use also 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 the user inserted the endoscope/ligation device down a patient's nose and this use is not within the intended use of the device, 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.
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in a biohazard bag within a clear plastic bag.The lot number was not returned with the device.The irrigation adapter, loading catheter, and bands were not returned with the device.Our laboratory evaluation of the product said to be involved could not confirm the report based on the condition of the returned device, the barrel was no longer attached to the trigger cord and no bands remained on the barrel.The trigger cord returned wrapped around the handle from deployment.There was a reddish brown substance present along the length of the trigger cord and on the barrel.A visual examination of the device was performed.The trigger cord was examined and all twelve 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 length of the trigger cord was measured between the knots and was within the tolerance.The trigger cord was intact and not broken.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, the barrel was no longer attached to the trigger cord and no bands remained on the barrel.The information provided indicated that the user inserted the endoscope/ligation device down a patient's nose.This use is not within the intended use of the device.The instructions for use states: "those specific to primary endoscopic procedure to be performed in gaining access to desired banding site." the instructions for use also 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 the user inserted the endoscope/ligation device down a patient's nose and this use is not within the intended use of the device, 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: 6 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: 18529037
• Report Number: 1037905-2024-00035
• Device Sequence Number: 15378562
• Product Code: MND
• UDI-Device Identifier: 00827002254244
• UDI-Public: (01)00827002254244(17)240906(10)W4762086
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/06/2024
• Device Catalogue Number: MBL-6-XS
• Device Lot Number: W4762086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2023
• 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-1100 220 1854
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown