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Model Number G31925 |
Device Problems
Fluid/Blood Leak (1250); Use of Device Problem (1670)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/23/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: inflation device-unknown make or model.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: the additional information indicated that negative pressure was not applied to the balloon prior to advancement through the endoscope accessory channel.A contributing factor to a leakage is failure to apply negative pressure to the balloon prior to advancement.This is the most likely cause for the reported observation.The instructions for use advise the user: "to facilitate passage through the endoscope, apply negative pressure to the catheter." the application of negative pressure will aspirate all residual air from the balloon and ease endoscopic advancement.Negative pressure will also aid in balloon preservation and optimize balloon performance.The instructions for use also advise the user: "maintain balloon deflation with negative pressure and introduce into the accessory channel of the endoscope, advancing in short increments until the dilator is completely visualized endoscopically." prior to distribution, all hercules 3 stage balloons esophageal are subjected to a leak test 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 currently being assessed and a follow up report will be sent.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 that no negative pressure was applied to the balloon, 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 esophagogastroduodenoscopy (egd), the physician used a cook hercules 3 stage balloon esophageal.As the balloon was inflated, leakage occurred.The procedure was completed with another hbd-10-11-12.A section of the device did not remain inside 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.
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Event Description
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During an esophagogastroduodenoscopy (egd), the physician used a cook hercules 3 stage balloon esophageal.As the balloon was inflated, leakage occurred.The procedure was completed with another hbd-10-11-12.A section of the device did not remain inside 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.
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Manufacturer Narrative
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Continued from section d11: inflation device-unknown make or model.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: the additional information indicated that negative pressure was not applied to the balloon prior to advancement through the endoscope accessory channel.A contributing factor to a leakage is failure to apply negative pressure to the balloon prior to advancement.This is the most likely cause for the reported observation.The instructions for use advise the user: "to facilitate passage through the endoscope, apply negative pressure to the catheter." the application of negative pressure will aspirate all residual air from the balloon and ease endoscopic advancement.Negative pressure will also aid in balloon preservation and optimize balloon performance.The instructions for use also advise the user: "maintain balloon deflation with negative pressure and introduce into the accessory channel of the endoscope, advancing in short increments until the dilator is completely visualized endoscopically." prior to distribution, all hercules 3 stage balloons esophageal are subjected to a leak test 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.Additional comments regarding this report: based on the information provided that no negative pressure was applied to the balloon, 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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