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Catalog Number MBL-6-F |
Device Problems
Positioning Failure (1158); Improper or Incorrect Procedure or Method (2017)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/18/2016 |
Event Type
malfunction
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Manufacturer Narrative
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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.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 an improper fit of the barrel to the scope leading to difficulty in deploying the bands.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.
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Event Description
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During an endoscopic variceal ligation procedure (evl), the physician used a cook 6 shooter saeed multi-band ligator.The physician said that the fourth band failed to deploy.They then replaced it with a new device to finish the procedure.
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Manufacturer Narrative
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Investigation evaluation: the product was returned with a trigger still attached to the barrel with two bands remaining on the barrel not deployed, a two-way handle and an irrigation adapter.The loading catheter was not returned with the device.A functional test was performed and a loading catheter was pulled from the lab stock to place the barrel onto the tip of the endoscope.During the functional test,` the device was put through an olympus upper gastrointestinal endoscope and both bands fired onto the simulated varices.The bands did not constrict immediately and took several minutes to constrict.After the functional test, the trigger cord became knotted and correct bead placement was unable to be confirmed.The lot number associated with this complaint was researched to determine the manufacturing date of the actual bands.We can conclude from the research that the bands were within the acceptable age date range to ensure the bands maintain their elasticity properties.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 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.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 an improper fit of the barrel to the scope leading to difficulty in deploying the bands.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.
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Search Alerts/Recalls
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