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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK ENDOSCOPY HERCULES 3 STAGE BALLOON ESOPHAGEAL; KNQ, DILATOR, ESOPHAGEAL
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COOK ENDOSCOPY HERCULES 3 STAGE BALLOON ESOPHAGEAL; KNQ, DILATOR, ESOPHAGEAL Back to Search Results
Model Number G31925
Device Problems Fluid/Blood Leak (1250); Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/23/2019
Event Type  malfunction  
Manufacturer Narrative
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.
 
Event Description
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.
 
Event Description
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.
 
Manufacturer Narrative
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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Brand Name
HERCULES 3 STAGE BALLOON ESOPHAGEAL
Type of Device
KNQ, DILATOR, ESOPHAGEAL
Manufacturer (Section D)
COOK ENDOSCOPY
4900 bethania station rd
winston-salem NC 27105
MDR Report Key9078377
MDR Text Key158995712
Report Number1037905-2019-00546
Device Sequence Number1
Product Code KNQ
UDI-Device Identifier00827002319257
UDI-Public(01)00827002319257(17)210122(10)W4020831
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/22/2021
Device Model NumberG31925
Device Catalogue NumberHBD-10-11-12
Device Lot NumberW4020831
Was Device Available for Evaluation? No
Date Manufacturer Received09/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
OLYMPUS ENDOSCOPE-UNKNOWN MODEL
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