MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC 4 SHOOTER SAEED MULTI-BAND LIGATOR; MND, LIGATOR, ESOPHAGEAL

Model Number	G22613
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During a gastroscopy with esophageal varices banding, the physician used a cook 4 shooter saeed multi-band ligator.It was reported that when the nurse installed the mbl-4 onto the endoscope, the physician tried to shoot [deploy] the band, but he found the band would not deploy, so he changed to another of the same device to successfully 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 an open pouch from the lot number provided in the report.The label matches the product returned.A photo was also received.The irrigation adapter and loading catheter were not included in the return.The photo provided shows the handle, barrel with all 4 bands and the trigger cord inside the opened tray.A red arrow pointing to the barrel can be seen on the picture, however there is no visible defect seen on the barrel.Our laboratory evaluation of the returned product could not confirm deployment difficulty.A functional test was performed.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 each band was 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 eight 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 was measured between the knots which is within the established 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.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 the reported observation could not be determined because the product said to be involved functioned as intended.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.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." band deployment difficulty can also 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 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 4 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: 4 SHOOTER SAEED MULTI-BAND LIGATOR
• Common Device Name: MND, LIGATOR, ESOPHAGEAL
• 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: 14372572
• Report Number: 1037905-2022-00218
• Device Sequence Number: 1983607
• Product Code: MND
• UDI-Device Identifier: 00827002226135
• UDI-Public: (01)00827002226135(17)221213(10)W4545976
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2022

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: 12/13/2022
• Device Model Number: G22613
• Device Catalogue Number: MBL-4
• Device Lot Number: W4545976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2021
• 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, UNKNOWN MODEL
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 58 KG