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Model Number N/A |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/05/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown or unavailable.E1: name and address: postal code: (b)(6).G4: pma/510(k) number = exempt this report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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It was reported that during a transurethral lithotomy (tul) procedure in the urinary tract, the physician tested the basket expansion function of an uncoiled ngage nitinol stone extractor before inserting into the endoscope.No issues were detected initially, but upon inspection on the endoscope screen, the physician observed a tear in the wire at the tip of the basket.A laser was not used while the basket was used.The procedure was successfully completed using another same device.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.The complainant has not reported any adverse effects on the patient due to this occurrence.
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Search Alerts/Recalls
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