Model Number M00535900 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/04/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).(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 used for the treatment of a common bile duct stone during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the cutting wire detached.Reportedly, no part of the device was detached inside the patient.The procedure was completed with a second ultratome xl.There were no patient complications reported as a result of this event.The patient's condition at the end of the procedure was reported to be stable.
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Manufacturer Narrative
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Block e1 (initial reporter address 1): (b)(6).Block h6 (device codes): the problem code 1069 captures the reportable event of cutting wire broken.Block h10: visual examination of the returned device revealed that the cutting wire was broken and blackened.In addition, the cutting wire was not smooth, confirming that it was not cut mechanically.The complaint was consistent with the reported event of cutting wire broke.It is most likely that a peak of voltage could have caused the failures noted.Therefore, the most probable cause of this complaint is adverse event related to procedure since it is the most likely that the adverse event occurred during the procedure and the device had no influence on event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release to distribution.
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Event Description
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It was reported to boston scientific corporation that an ultratome xl was used for the treatment of a common bile duct stone during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the cutting wire detached.Reportedly, no part of the device was detached inside the patient.The procedure was completed with a second ultratome xl.There were no patient complications reported as a result of this event.The patient's condition at the end of the procedure was reported to be stable.
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Search Alerts/Recalls
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