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

Catalog Number MBL-6-OV

Device Problem Positioning Failure (1158)

Patient Problems Hemostasis (1895); No Consequences Or Impact To Patient (2199); Laceration(s) of Esophagus (2398)

Event Date 12/29/2015

Event Type  Injury  

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 conclusions: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.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: "the use of an endoscope in a sound state of repair is a prerequisite for a successful multi-band ligation procedure." another possible contributing factor to band deployment difficulty includes allowing the trigger cord to become lodged between the barrel and the distal end of the endoscope.This can restrict trigger cord movement and result in band deployment difficulty.Band deployment difficulty can occur if the trigger cord is not properly seated in the handle assembly.The instructions for use advise the user that the knot must be seated into the hole or the handle will not function properly.The instructions for use direct the user to place the handle in the two-way position and loosen the trigger cord slightly if the band will not deploy.The user is then instructed to return the handle to the firing position and continue with deployment of the band(s).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 difficulties.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 variceal ligation (evl) procedure, the physician used a cook 6 shooter saeed multi-band ligator.The location was the mid and lower third of the esophagus.The device was loaded onto the endoscope.They successfully placed the first band on a varix.After that, they were unable to fire a second band.They repositioned the endoscope and attempted to fire again but it did not fire.They then removed the scope from the body.When they removed the scope, they found some esophageal tissue on the cap.They took the device off and placed another of the same device on.When they went back down into the patient, they saw that the area where the esophageal tissue came from was actively bleeding.The second bander was unsuccessful at stopping the bleeding.A hemostasis clip was used to stop the bleeding.Because of this, the patient was intubated and admitted to the intensive care unit (icu).The patient has since been discharged to home.On (b)(6) 2016, the cook representative provided the following information in regards to why the patient was sent to the intensive care unit (icu) and intubated: i believe it was just for precaution since the patient bled so much.The tube was placed because patient was actively bleeding and throwing up blood, the tube was placed to protect the airway.The representative also provided information that when the endoscope was withdrawn, tissue was found between the bands on the device.

Event Description

This follow up report is being sent due to a user facility medwatch, reference number mw5060087, report being received.During an endoscopic variceal ligation (evl) procedure, the physician used a cook 6 shooter saeed multi-band ligator.The location was the mid and lower third of the esophagus.The device was loaded onto the endoscope.They successfully placed the first band on a varix.After that, they were unable to fire a second band.They repositioned the endoscope and attempted to fire again but it did not fire.They then removed the scope from the body.When they removed the scope, they found some esophageal tissue on the cap.They took the device off and placed another of the same device on.When they went back down into the patient, they saw that the area where the esophageal tissue came from was actively bleeding.The second bander was unsuccessful at stopping the bleeding.A hemostasis clip was used to stop the bleeding.Because of this, the patient was intubated and admitted to the intensive care unit (icu).The patient has since been discharged to home.On 01/28/2016, the cook representative provided the following information in regards to why the patient was sent to the intensive care unit (icu) and intubated: i believe it was just for precaution since the patient bled so much.The tube was placed because patient was actively bleeding and throwing up blood, the tube was placed to protect the airway.The representative also provided information that when the endoscope was withdrawn, tissue was found between the bands on the device.The following information was provided per facility medwatch report received by cook on 03/14/2016 - banding mechanism did not deploy appropriately.Banding was unsuccessful.

• Brand Name: 6 SHOOTER SAEED MULTI-BAND LIGATOR
• Type of Device: MND, LIGATOR, ESOPHAGEAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 5398761
• MDR Text Key: 37106391
• Report Number: 1037905-2016-00016
• Device Sequence Number: 1
• Product Code: MND
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2016,03/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MBL-6-OV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/05/2016
• Distributor Facility Aware Date: 12/29/2015
• Device Age: 1 MO
• Event Location: Hospital
• Date Manufacturer Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 33 YR