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Model Number M00535920 |
Device Problem
Positioning Problem (3009)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/28/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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Event Description
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Note: this report pertains to the second of two ultratome xl devices used during the same procedure.It was reported to boston scientific corporation that an ultratome xl was used in the common bile duct (cbd) during an endoscopic sphincterotomy (est) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the direction of the cutting wire was incorrect.A second ultratome xl was used; however, during the procedure, the direction of the cutting wire was still incorrect.The procedure was completed with another of the same device.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 stable.
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Manufacturer Narrative
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Block h6 (device codes): problem code a1502 captures the reportable event of incorrect cutting wire orientation.Block h10: the returned ultratome xl was analyzed, and a visual evaluation noted that the cutting wire and the working length were bent at the distal section.A functional evaluation noted that the initial orientation of the distal tip of the device when exiting the endoscope was correct; however, the cutting wire was not aligned since it was bent.No other problems with the device were noted.The reported complaint was confirmed.Upon analysis, it was found that the cutting wire and the working length were bent causing an incorrect orientation of the cutting wire.Based on the condition of the device, the problem found could have been caused by the manipulation of the device while advancing into the scope and anatomy or if the device was hit against a surface.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on the event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
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Event Description
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Note: this report pertains to the second of two ultratome xl devices used during the same procedure.It was reported to boston scientific corporation that an ultratome xl was used in the common bile duct (cbd) during an endoscopic sphincterotomy (est) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the direction of the cutting wire was incorrect.A second ultratome xl was used; however, during the procedure, the direction of the cutting wire was still incorrect.The procedure was completed with another of the same device.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 stable.
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Search Alerts/Recalls
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