Catalog Number 8065752134 |
Device Problems
Failure to Cut (2587); Gas/Air Leak (2946)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Event Description
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A physician reported cutting failure of a probe occurred, aspiration condition unknown during a surgery.The product was replaced and the surgery was completed.There was no patient harm.The procedure type is unknown.
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Manufacturer Narrative
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A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The customer returned one probe.The probe was visually inspected and it was found that the clear tubing detached from the probe engine.A lack of solvent was applied around the tubing that caused the tubing not to adhere on the wall of the probe engine port.The root cause of the customer's complaint is a lack of solvent application at the location where the tubing is inserted into the probe engine.This complaint has been reviewed and it is determined that no further actions will be pursed at this time.Based on our current tracking, there are no adverse trends for this reported complaint.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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