During an endoscopy procedure to dilate the colon, a cook hercules 3 stage wireguard balloon esophageal-pyloric-colonic was used.The physician was using a pediatric colonoscope, and while attempting to pull the balloon through the endoscope at the end of the procedure, the tip of the balloon broke off.It is unknown if the detached tip was retrieved or left to pass naturally.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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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 conclusions: 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.Instructions for use state: "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use." according to the report the physician thought this occurrence was due to the small channel size of the pediatric scope.The recommended minimum channel size for this device is 2.8mm.Prior to distribution, all cook hercules 3 state wireguided balloon esophageal-pyloric-colonic balloons are subjected to a visual inspection and functional testing 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 and this represents an unusual occurrence.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.
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