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Model Number M0063901050 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/11/2020 |
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 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 zero tip stone retrieval baket was to be used in a procedure on (b)(6) 2020.According to the complainant, during preparation, a black stain was noted on the "pb".No patient complications were reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
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Manufacturer Narrative
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H10 block h6: device code 2944 captures the reportable event of "black stain was noted on the pb".Block h10: the zero tip basket was returned in its original unopened pouch.Visual analysis found the heat seal ran throughout the entire length of the pouch without any breakage.Black stains was observed in the front section of the pouch outside the sterile area.No other issues were identified.Based on all available information, it is most likely that handling and manipulation of the device during transport/storage contributed to the observed issue.It is also probable that how the device was handled and manipulated during the processes of shipping/receiving, storage, or packing inside of the generic bag could have contributed to the observed issue.Therefore, the most probable root cause is cause traced to transport/storage.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 for distribution.
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Event Description
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It was reported to boston scientific corporation that a zero tip stone retrieval baket was to be used in a procedure on (b)(6) 2020.According to the complainant, during preparation, a black stain was noted on the "pb".No patient complications were reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
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Search Alerts/Recalls
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