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

Catalog Number MBL-U-6

Device Problems Positioning Failure (1158); Premature Activation (1484); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: during the laboratory evaluation, the two way handle, trigger cord, and irrigation valve were visually examined.The barrel, bands, or loading catheter were not included in the return of the device.An evaluation of the handle wheel movement was performed and the wheel functioned as intended.The trigger cord was examined and the length of the trigger cord was measured to be within specification.The beads on the trigger cord were examined and all were found to be present; however, one bead was not in the correct location on the inspection plate.If extreme pressure were applied to the handle in response to resistance, this could contribute to trigger cord breakage, bead loss, and/or bead movement.Missing and movement of the trigger cord beads likely allowed the trigger cord to disconnect from the band and barrel causing difficulty with deployment.The trigger cord was intact and not broken.The lot number associated with this complaint was researched to determine the manufacturing date of the actual bands.The bands were within the acceptable age date range to ensure the bands maintain their elasticity properties.For lot number, w3617230, the sub lot number was reviewed and the tensile test for bead integrity passed testing.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: a definitive cause for the reported observation could not be determined because the condition of the product said to be involved prohibited a complete evaluation.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: "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).Premature band deployment can also occur if the handle is placed in the firing position before the endoscope is in place inside the patient.The instructions for use direct the user to keep the handle in the two-way position prior to introducing the endoscope.After intubation, the instructions for use direct the user to place the handle in the firing position.During the procedure, endoscopic suction is applied to the banding site to properly place a ligator band.Premature band deployment can also occur if the handle is rotated before maintaining suction on the banding site.The instructions for use advise the user to maintain suction while deploying the band.If the ligator handle is in the firing position while the endoscope is straightened, this can result in premature band deployment due to tension on the trigger cord.The instructions for use direct the user to place the handle in the two-way position before straightening the endoscope.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.Investigation evaluation: during the laboratory evaluation, the two way handle, trigger cord, and irrigation valve were visually examined.The barrel, bands, or loading catheter were not included in the return of the device.An evaluation of the handle wheel movement was performed and the wheel functioned as intended.The trigger cord was examined and the length of the trigger cord was measured to be within specification.The beads on the trigger cord were examined and all were found to be present; however, one bead was not in the correct location on the inspection plate.If extreme pressure were applied to the handle in response to resistance, this could contribute to trigger cord breakage, bead loss, and/or bead movement.Missing and movement of the trigger cord beads likely allowed the trigger cord to disconnect from the band and barrel causing difficulty with deployment.The trigger cord was intact and not broken.The lot number associated with this complaint was researched to determine the manufacturing date of the actual bands.The bands were within the acceptable age date range to ensure the bands maintain their elasticity properties.For lot number, w3617230, the sub lot number was reviewed and the tensile test for bead integrity passed testing.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.

Event Description

During an endoscopy procedure, the physician used a cook 6 shooter saeed multi-band ligator.The first band would not deploy and then three bands deployed at once [premature deployment].

• 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: 5189477
• MDR Text Key: 30241190
• Report Number: 1037905-2015-00471
• 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
• Type of Report: Initial
• Report Date: 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MBL-U-6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 2 MO
• Event Location: Hospital
• Date Manufacturer Received: 10/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2015
• 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