This is report 6 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.
|
The lot number was unknown.Therefore, the device manufacture date was unknown.The reporter indicated that the device was not saved.The device has not been returned as this is a single-use instrument; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.
|