Catalog Number 8065797003 |
Device Problem
Appropriate Term/Code Not Available (3191)
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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 customer reported that during surgery when opened a new cylinder for sulphur hexafluoride(sf6) did show that the cylinder is full and took only 10 cc from it, then the regulator went to the empty sign right away.The procedure was completed.
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Event Description
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Additional information received indicated that regulator was missing an o-ring and that is why the gas had leaked from the sulphur hexafluoride (sf6) cylinder.
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Manufacturer Narrative
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The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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A check of the batch production record for lot showed no unusual manufacturing issues.A check of the complaint records showed no other complaints against lot.A check of confirmed complaints of this type, showed there have been eight since the beginning of 2015.One cylinder of this lot was in good condition as received.The cylinder was weighed and found to be empty.Based upon the information provided, the root cause of the reported event cannot be determined.At this time, the root cause of the reported event cannot be determined.Manufacturer 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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