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

Catalog Number MBL-6-F

Device Problems Positioning Failure (1158); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2016

Event Type  malfunction  

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 conclusion: 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: " 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 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).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.The information provided from the user facility indicated an olympus gif 160 endoscope was used, which has an outer diameter of 8.6 mm.This ligator is not compatible with the endoscope used in the procedure as the information indicated.This ligator is compatible with endoscopes that have an outer diameter of 9.5 mm-11.3 mm only.If the ligator is used with an incompatible endoscope this could cause barrel detachment.The endoscope recommended for the mbl-6-f device is a fujinon model endoscope.If the ligator is used with an incompatible endoscope this could cause barrel detachment.Prior to distribution, all 6 shooter saeed multi-band ligator 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 actions: 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.Additional comments regarding this report: based on the information provided, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

Event Description

During an endoscopic variceal ligation procedure (evl), the physician used a cook 6 shooter saeed multi-band ligator.The surgeon said that the second band failed to deploy.They then replaced it with a new device to finish the procedure.

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved could not confirm the report as it was described.The product was returned with a two-way handle, a loading catheter, an irrigation adapter, a trigger cord, and a barrel with two bands still on the barrel.The trigger cord was not attached to the barrel.A visual examination of the trigger cord was performed and all twelve (12) beads were present.The twelve (12) beads were examined using magnification and all twelve (12) beads were correctly filled.The location of the beads were verified and through a visual inspection the beads on one side of the trigger cord are not in the correct location.The beads could have moved during usage of the device.The length of the trigger cord was measured to be within specification.The trigger cord was intact and not broken.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.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 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 hole or handle will not function properly." the instructions for use direct the user to "place 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).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.The information provided from the user facility indicated an olympus gif 160 endoscope was used, which has an outer diameter of 8.6mm.This ligator is not compatible with the endoscope used in the procedure as the information indicated.This ligator is compatible with endoscopes that have an outer diameter of 9.5mm-11.3mm only.The endoscope recommended for the mbl-6-f device is a fujinon model endoscope.If the ligator is used with an incompatible endoscope this could cause barrel detachment.Prior to distribution, all 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 actions: 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.Additional comments regarding this report: based on the information provided, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

• 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: 5637059
• MDR Text Key: 44676721
• Report Number: 1037905-2016-00129
• Device Sequence Number: 1
• Product Code: MND
• UDI-Device Identifier: 00827002226920
• UDI-Public: (01)00827002226920(17)161117(10)W3649831
• Combination Product (y/n): N
• Reporter Country Code: CN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MBL-6-F
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/08/2016
• Device Age: 5 MO
• Event Location: Hospital
• Date Manufacturer Received: 06/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2015
• 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 Age: 66 YR
• Patient Weight: 46