LITTLE LOTTA VENTRICULOSCOPE

Additional Manufacturer Narrative

THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4). CROSS REFERENCE INTERAL COMPLAINT ID (B)(4).

Description of Event or Problem

IT HAS BEEN REPORTED THAT METAL SHAVINGS MAY HAVE DETACHED FROM THE SCOPE. METAL FLAKES/ SHAVINGS WERE VISIBLE ON THE ENDOSCOPE'S SURGICAL IMAGE. THESE WERE FLOATING AROUND IN THE VENTRICULAR SPACE. IT WAS NOT CLEAR WHETHER THESE CAME FROM THE ENDOSCOPE ITSELF, THE INSTRUMENTS USED, OR ANOTHER SOURCE. CONCOMITANT DEVICE FILED UNDER INTERNAL COMPLAINT ID (B)(4).