BOSTON SCIENTIFIC - SPENCER SPYSCOPE DS ACCESS & DELIVERY CATHETER; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
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Model Number M00546600 |
Device Problems
Detachment Of Device Component (1104); Material Protrusion/Extrusion (2979)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/16/2016 |
Event Type
malfunction
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Manufacturer Narrative
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According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2016.According to the complainant, during the procedure, as the spyscope ds was inserted into the bile duct, it was noticed on the monitor that there was something that looked like a piece of metal protruding out of the spyscope.The physician removed the scope from the patient, and pulled out the working channel sleeve from the working channel of the spyscope.There was no other visible damage noted.The physician continued using this device and completed the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
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Manufacturer Narrative
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(b)(4) working channel sleeve detached.
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Event Description
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It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2016.According to the complainant, during the procedure, as the spyscope ds was inserted into the bile duct, it was noticed on the monitor that there was something that looked like a piece of metal protruding out of the spyscope.The physician removed the scope from the patient, and pulled out the working channel sleeve from the working channel of the spyscope.There was no other visible damage noted.The physician continued using this device and completed the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
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