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Catalog Number SHORT_LL |
Device Problems
Contamination (1120); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/29/2014 |
Event Type
Injury
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Event Description
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This is report 1 of 8 for the same event.It was reported that during an unspecified pediatric surgery, it was observed that when using the cutting burr device, motor device and attachment device, it was observed that a black fluid sprayed from the attachment device into the field.The reporter stated that it remained unclear as to which of the six attachment devices was in use at the time of the event.There was a delay to the surgical procedure; however, the time of delay was unknown to the reporter.There was an identical spare motor device available for use.There was patient involvement reported.It was not reported if there were injuries or prolonged hospitalization.However, the patient was treated with unknown antibiotics.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Manufacturer Narrative
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The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that there was foreign debris in the lumen of the device.It was determined that during use, irrigation fluid wicks up the shaft of the cutter device and mixes with the debris inside the attachment.When the drill is stopped, the fluid runs out the distal tip of the attachment device and has a black tint to it.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to improper cleaning which was misuse, abuse, and/ or user error.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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