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Model Number M00535150 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/26/2019 |
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 a stonetome was used in the papilla during an endoscopic biliary stone removal procedure performed on (b)(6) 2019.According to the complainant, during the procedure, when incision was performed, it was noticed that the cutting wire broke.Reportedly, no part of the device was detached inside the patient.The procedure was completed with a second stonetome, using the same generator and active cord.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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(device codes): the problem code 1069 captures the reportable event of cutting wire broken.Visual examination of the returned device revealed that the cutting wire was broken and blackened.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 or if the cutting wire was not in contact with the tissue when it was energized.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 a stonetome was used in the papilla during an endoscopic biliary stone removal procedure performed on (b)(6) 2019.According to the complainant, during the procedure, when incision was performed, it was noticed that the the cutting wire broke.Reportedly, no part of the device was detached inside the patient.The procedure was completed with a second stonetome, using the same generator and active cord.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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