Model Number N/A |
Device Problem
Inflation Problem (1310)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/09/2024 |
Event Type
malfunction
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Event Description
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It was reported that the balloon of an arndt endobronchial blocker set was difficult to inflate during a frozen lung biopsy procedure.The catheter was inserted into the airway of the patient and filled with gas to inflate the balloon.However, the balloon was not able to be inflated to the desired sealing state.Therefore, the device was removed and replaced with another like device to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures 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.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.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or 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 was received indicating that balloon inflation was tested before insertion into the multiport adaptor.
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Manufacturer Narrative
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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.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Search Alerts/Recalls
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