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Model Number M0063902010 |
Device Problems
Break (1069); Difficult to Open or Close (2921); Material Split, Cut or Torn (4008)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/04/2020 |
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 escape basket was used in the kidney during a ureteroscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the escape basket was used and retrieved four stones.However, when attempting to retrieve the fifth stone, the basket failed to close completely around the stone.Additionally, the basket wire was reported to have been broken but remained attached to the device, and the sheath was torn at the distal end.Another escape basket was used to complete the procedure.There were no patient complications 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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