MAUDE Adverse Event Report: COOK ENDOSCOPY 6 SHOOTER SAEED MULTI-BAND LIGATOR; MND, LIGATOR, ESOPHAGEAL

Model Number	G24654
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During an esophagogastroduodenoscopy (egd), the physician used a cook 6 shooter saeed multi-band ligator.It was reported that they were banding a patient and the cord on the bander frayed.The procedure was successfully completed with another device of the same type.There was no reportable information at this time as there was no difficulty noted, just fraying.The device was received and the bands were deployed in the packaging.Due to the sum of the originally reported information and the state the device was received in, it is reasonable to conclude that the device was difficult to use [subject of report].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: the product said to be involved was returned in an open box from the lot number provided in the report.The label matches the product returned.The loading catheter, two-way handle, and the irrigation adapter were not included in the return.Our laboratory evaluation of the returned product confirmed deployment difficulty as there were 3 deployed and constricted bands laying in the tray when received.Only 2 bands remained on the barrel and band 5 had moved halfway down the barrel and was not in the correct position.The trigger cord was found to be severely frayed at the proximal end.The trigger cord was stretched back out and a functional test was performed.Using a two-way handle and loading catheter from our stock, the multi-band ligator device was attached to an endoscope that was placed in a simulated gastrointestinal position with vacuum attached.The endoscope has an accessory channel that is 2.8 mm in diameter (olympus 2.8 gif q20 endoscope).The multi-band ligator barrel was attached onto the end of the endoscope.Simulated varices were placed at the end of the barrel and vacuum pulled and the 2 remaining bands were fired.It was observed that the bands constricted and functioned as intended.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 using bead inspection plate.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 after being stretched back out was measured between the knots and is within tolerance.The trigger cord was intact and not broken but when received had been frayed on the proximal end.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: 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.Difficulty in effectively deploying bands 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 precaution: "use of an endoscope in a sound state of repair is a prerequisite for a successful multi-band ligation procedure." band deployment difficulty can occur if the trigger cord is not properly seated in the handle assembly.The instructions for use advise the user: "note: knot must be seated into hole or handle will not function properly." a precaution in the instructions for use states: "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 for the lot number confirmed that this lot 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: 6 SHOOTER SAEED MULTI-BAND LIGATOR
• Common Device Name: MND, LIGATOR, ESOPHAGEAL
• Manufacturer (Section D): COOK ENDOSCOPY; 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: 12799039
• Report Number: 1037905-2021-00624
• Device Sequence Number: 20231139
• Product Code: MND
• UDI-Device Identifier: 00827002246546
• UDI-Public: (01)00827002246546(17)220823(10)W4508513
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/23/2022
• Device Model Number: G24654
• Device Catalogue Number: MBL-6-OV
• Device Lot Number: W4508513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2021
• 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: ENDOSCOPE - OLYMPUS 190
• Patient Sex: Unknown