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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK ENDOSCOPY HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC KNQ, DILATOR, ESOPHAGEAL

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COOK ENDOSCOPY HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC KNQ, DILATOR, ESOPHAGEAL Back to Search Results
Catalog Number HBD-W-12-13.5-15
Device Problems Hole In Material; Leak / Splash
Event Date 10/23/2017
Event Type  Malfunction  
Manufacturer Narrative

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. 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. It is unknown if the user applied negative pressure and lubrication to the balloon prior to advancement down the endoscope accessory channel. A possible contributing factor to a leakage in the balloon material is failure to apply negative pressure and lubrication to the balloon prior to advancement through the endoscope. The instructions for use direct the user: "to facilitate passage through the endoscope, apply negative pressure to the device. " 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 endoscope accessory channel, advancing in short increments until balloon is completely visualized endoscopically. ¿ the instructions for use direct the user to: "apply a lubricating agent to the balloon to facilitate passage through the endoscope accessory channel. " this activity will aid in endoscopic advancement and balloon preservation. Leakage in the balloon material can occur if the balloon is inflated prior to advancement through the endoscope or if the balloon is inflated while partially or fully inside the accessory channel of the endoscope. The instructions for use contain the following precaution: ¿do not pre-inflate the balloon. ¿ a leakage in the balloon can also occur if the balloon material comes into contact with a sharp object or a burr in the endoscope channel. The instructions for use contain the following warning: ¿during dilation, do not inflate balloon beyond the maximum indicated inflation pressure, as this could result in overextension or bursting of the balloon. " another possible contributing factor is using a compromised inflation device to inflate the balloon. If the pressure reading of the inflation device is inaccurate, this could contribute to over-inflation, possibly resulting in damage to the balloon material. Prior to distribution, all hercules 3 stage wireguided balloon esophageal-pyloric-colonic are subjected to a visual examination 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. 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.

 
Event Description

During a procedure, they physician chose a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic. The balloon [could not] be inflated because of leakage.

 
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Brand NameHERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC
Type of DeviceKNQ, DILATOR, 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 Key7074139
Report Number1037905-2017-00728
Device Sequence Number1
Product CodeKNQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/18/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/01/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberHBD-W-12-13.5-15
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/23/2017
Device Age7 mo
Event Location Hospital
Date Manufacturer Received11/30/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/20/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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