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Model Number M0063901050 |
Device Problems
Difficult to Open or Close (2921); Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/01/2021 |
Event Type
malfunction
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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.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.
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Event Description
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It was reported that a zero tip basket was used in the urinary tract during a urolithotripsy procedure performed on an unknown date.During the procedure, the basket became difficult to open or close and the sheath was torn at the distal end.Procedure was still able to be completed with this device.There were no patient complications as a result of this event.
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Search Alerts/Recalls
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