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Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.Initial reporter also sent report to fda?: user medwatch number: mw5090146.The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.(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 medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation that an escape retrieval basket was used during a ureteroscopy procedure performed on an unknown date.According to the complainant, during the procedure, at the time of using the laser, the physician was holding the stone when approximately 1mm of one of the basket wires broke off.The physician attempted to locate the broken fragment and retrieve it with urethral biopsy forceps; however, the physician was unable to locate the fragment because it was too small.Reportedly, in the physician's assessment, the fragment does not represent any dangers to the patient.There were no reported patient complications as a result of this event.
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Search Alerts/Recalls
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