Model Number M00535900 |
Device Problem
Positioning Problem (3009)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/17/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that an ultratome xl was in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the orientation of catheter tip and cutting wire were incorrect.The procedure was completed with a second ultratome xl.There were no patient complications reported as a result of this event.
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Event Description
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It was reported to boston scientific corporation that an ultratome xl was in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the orientation of catheter tip and cutting wire were incorrect.The procedure was completed with a second ultratome xl.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block d4, h4: the complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.Block h6 (device codes): problem code 3009 captures the reportable event of cutting wire orientation.Block h10: visual analysis of the returned device found in good conditions.Functionally, the device was introduced inside the duodenoscope, and the cutting wire position was found within the specifications.Based on all compiled information on this investigation, the most probable cause is no problem detected since the complaint included a returned device review which showed no evidence of either the alleged issue or any defect which could have contributed to the event.
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Search Alerts/Recalls
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