MAUDE Adverse Event Report: COOK ENDOSCOPY 10 SHOOTER SAEED MULTI-BAND LIGATOR; FHN, LIGATOR, HEMORRHOIDAL

Model Number G31919

Device Problem Failure to Fire (2610)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/24/2021

Event Type  malfunction  

Manufacturer Narrative

Occupation - unknown.Investigation evaluation: a product evaluation was performed only by the video provided with this report because the product said to be involved was not provided to cook for evaluation.A photo/video of the lot number was not provided.In the video provided, two (2) bands can be seen on the barrel - one (1) amber band and one (1) black band.As the trigger cord is being pulled, it is the black band that moves, not the amber band.This indicates that the beads for the amber band are not in position to deploy the amber band.The video does confirm difficulty in effectively deploying the bands.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.Based on the review of the video we could confirm the beads on the trigger cord are not in the correct position to deploy the amber band.However, 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." 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: 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.

Event Description

During an endoscopic hemorrhoidal ligation (ehl), the physician used a cook 10 shooter saeed multi-band ligator.The physician released the first two (2) bands successfully.The third band could not be released.Other than 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.

Manufacturer Narrative

Initial reporter section: occupation - unknown.Investigation evaluation: the product said to be involved was returned in an open box/ tray from the lot number provided in the report.The label matches the product returned.Missing from the return were the irrigation adapter and the loading catheter.A video was also provided by the customer.In the video provided, two (2) bands can be seen on the barrel - 1 amber band and 1 black band.As the trigger cord is being pulled, it is the black band that moves, not the amber band.This indicates that the beads for the amber band are not in position to deploy the amber band.The video does confirm difficulty in effectively deploying the bands.Our laboratory evaluation of the returned product also confirmed the difficulty deploying the bands.The trigger cord, the barrel with 1 black band remaining on it and the two-way handle were included in the return.During our laboratory analysis, a visual examination of the device was performed.The trigger cord was not attached to the barrel.As a result, a functional test could not be performed.The trigger cord was examined and all twenty (20) deployment beads were present.Correct location of the beads were verified.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 within the tolerance.The trigger cord was intact and not broken.An evaluation of the handle wheel movement was also performed and the wheel functioned as intended.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 due to the condition of the returned device said to be involved.The trigger cord was no longer connected to the barrel prohibiting further testing to deploy the remaining band on the barrel.Review of the video did confirm the beads on the trigger cord are not in the correct position to deploy the amber band.However, 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." 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: 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.

• Brand Name: 10 SHOOTER SAEED MULTI-BAND LIGATOR
• Type of Device: FHN, LIGATOR, HEMORRHOIDAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 11378952
• MDR Text Key: 267696900
• Report Number: 1037905-2021-00077
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 00827002319196
• UDI-Public: (01)00827002319196(17)210615(10)W4354721
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 03/25/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2021
• Device Model Number: G31919
• Device Catalogue Number: MBL-U-10
• Device Lot Number: W4354721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Initial Date Manufacturer Received: 02/01/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 03/01/2021
• Supplement Dates FDA Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FUJI EG-601WR ENDOSCOPE; OLYMPUS GIF-Q260J GASTROSCOPE
• Patient Age: 35 YR