Model Number M00535920 |
Device Problem
Positioning Problem (3009)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/08/2019 |
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 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 in the common bile duct (cbd) during a stone removal procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the scope elevator was in neutral position when it was noticed that the cutting wire orientation was incorrect.Reportedly, there was no tortuous anatomy impacting scope positioning and no visible damage to the device prior to putting it through the scope or after the issue occurred.The procedure was completed with a different 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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Device codes: the problem code 3009 captures the reportable event incorrect cutting wire orientation.Visual examination of returned product revealed that the working length was twisted and the cutting wire was kinked at the distal section.The complaint was consistent with the reported event of incorrect orientation which could have been affected by twisted working length.Working length twisted and cutting wire kinked are known issues caused during manipulation of the device or due to the interaction with the endoscope or with other devices.Based on all compiled information on this investigation, the most probable cause of this complaint is adverse event related to procedure, the adverse event occurred during the procedure and the device had no influence on the 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.Correction to device manufacture date.
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Event Description
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It was reported to boston scientific corporation that an ultratome xl was used in the common bile duct (cbd) during a stone removal procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the scope elevator was in neutral position when it was noticed that the cutting wire orientation was incorrect.Reportedly, there was no tortuous anatomy impacting scope positioning and no visible damage to the device prior to putting it through the scope or after the issue occurred.The procedure was completed with a different 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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