COOK INC AMPLATZ ULTRA STIFF PTFE DOUBLE FLEXIBLE WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
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Model Number N/A |
Device Problem
Unraveled Material (1664)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/23/2024 |
Event Type
malfunction
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Event Description
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It was reported, the amplatz ultra stiff ptfe double flexible wire guide uncoiled during an unspecified procedure.There was no harm to the patient, however it caused inconvenience.No section of the device remained inside the patient's body.There were no adverse effects on the patient due to this occurrence.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.
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Manufacturer Narrative
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E1: customer postal code = (b)(6).E3: customer occupation = sr.Clinical risk advisor.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 procedure was a cystoscopy with ureteral stent exchange.The wire uncoiled when it was being removed from the wire guide after stent placement and was not used through a needle.There was not any resistance when placing the wire guide, but some resistance when it was being removed after the stent placement.The last step to complete the procedure was to remove the wire guide, so another device was not necessary.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown or unavailable.H3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.Device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.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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