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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
Catalog Number HBD-12-13.5-15
Device Problems Hole In Material; Leak / Splash; Improper or Incorrect Procedure or Method
Event Date 10/20/2017
Event Type  Malfunction  
Manufacturer Narrative

Investigation evaluation the product said to be involved was returned in an open pouch from the lot number provided in the report. The label matches the product returned. Our laboratory evaluation of the product said to be involved confirmed the report. During a functional test, a cook ds-60cc-s syringe was filled with water and attached to the balloon inflation port. The syringe was placed into an inflation handle, and negative pressure was applied to the balloon. After applying negative pressure, inflation of the balloon was attempted. The balloon would not hold pressure and a leakage was observed from a pinhole in the middle of the balloon material. A visual examination of the catheter showed no kinks or bends. A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis. 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 product preparation and handling conditions could not be duplicated in the laboratory setting. This limits our ability to conclusively determine a cause. The additional information provided indicated that the balloon was inflated prior to use. The user is advised not to inflate the balloon prior to advancement through the endoscope accessory channel. The instructions for use caution the user: "do not pre-inflate the balloon. " a pinhole in the balloon material may occur if the balloon contacts something sharp during device preparation. Prior to distribution, all hercules 3 stage balloon esophageal are subjected to a visual inspection and functional testing to ensure device integrity. The functional tests consist of a flow and leak test. Any nonconforming devices would have been removed prior to distribution. 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 inflated prior to use [against the instructions for use], 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

In preparation for a procedure, the physician chose a cook hercules 3 stage balloon esophageal. Prior to patient contact, the user attempted to inflate the balloon to check if the balloon would inflate properly. However the balloon would not inflate and the user found the injected saline was leaking from the balloon. He replaced it with another hbd-12-13. 5-15 [cook hercules 3 stage balloon esophageal] to complete the procedure.

 
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Brand NameHERCULES 3 STAGE BALLOON ESOPHAGEAL
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 Key7022619
Report Number1037905-2017-00682
Device Sequence Number1
Product CodeKNQ
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial
Report Date 11/10/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/10/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberHBD-12-13.5-15
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/20/2017
Device Age2 mo
Event Location Hospital
Date Manufacturer Received10/20/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/09/2017
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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