During a literature review of the paper 'sendino o, fernandez-esparrach g, sole m et al.Endoscopic ultrasonography-guided brushing increases cellular diagnosis of pancreatic cysts: a prospective study.Digestive and liver disease 2010; 42: 877-881' the following incident was noted; in an eus-guided cytology brushing procedure, one patient developed a mild pancreatitis and recovered with standard treatment a few days later.
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Although no device malfunction has been reported, this incident meets the criteria of a serious injury report based on the intervention to treat mild pancreatitis that developed following the use of an echobrush endoscopic ultrasound cytology brush.This complaint is related to an echo-19-cb device of an unknown lot number.The echo-19-cb device involved in this complaint has not been returned for evaluation.With the information provided, a document based investigation was carried out.The complaint is considered based on the customer testimony.Clinical personnel were notified of this complaint and the following comments were provided: "pancreatitis is a known complication of ercp." it was the clinician's opinion that the reported adverse event was related to the clinical procedure and/or patient condition." as the echo device was not returned for evaluation and no specific device malfunction was noted during the procedure it is not possible to determine the root cause of this complaint however it is most likely procedure and/or patient condition related.As stated on the instructions for use that accompanies this device, potential complications with gastrointestinal endoscopy include, but are not limited to: perforation, hemorrhage, aspiration, fever, infection, allergic reaction to medication, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest.The manufacturing records of the device involved in this complaint could not be reviewed as the lot number of the complaint device was not provided.The patient recovered with standard treatment a few days later.Complaints of this nature will continue to be monitored for potential emerging trends.
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