COOK INC NCIRCLE TIPLESS STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL
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Model Number N/A |
Device Problem
Difficult to Open or Close (2921)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/18/2024 |
Event Type
malfunction
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Event Description
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As reported, during a stone removal procedure, an ncircle tipless stone extractor's basket did not open.The procedure was completed using another same type device.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures or experience any adverse effects due to this occurrence.
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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- phone:(b)(6).G4 - pma/510(k)#: 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 or that a death or serious injury occurred; nor is it admission 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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Manufacturer Narrative
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H3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.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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Additional information received 22feb2024.The device failure was noted while the device was in contact with the patient.
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Search Alerts/Recalls
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