OtherEBR
ALLEGIANCE POOLE SUCTION INSTRUMENT
Received Oct 18, 2002 · Event occurred Sep 1, 2002
Report 2433012-2002-00001 · MDR key 423752
Device
Generic name
Poole Suction Instrument
Manufacturer
Busse Hospital DisposblesModel number
*Catalog number
K770
Lot number
UNK
Product problems
- Break
- Use of Device Problem
- Component Missing
Patient
*
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
PHYSICIAN PHONED DISTRIBUTOR AND STATED THAT HE WAS USING THE POOLE SUCTION HANDLE DURING AN ORTHOPEDIC SURGERY AND HE USED THE HANDLE TO PUSH ON A STRUCTURE IN THE SHOULDER AND THE HANDLE BROKE. A PIECE BROKE OFF. PHYSICIAN NOT CERTAIN WHERE THE PIECE IS. CT SCAN WAS DONE AND THE PIECE COULD NOT BE FOUND. PHYSICIAN ADMITTED TO USER ERROR. HE JUST WANTED TO KNOW IF IT WAS IN THE PATIENT COULD HE LEAVE IT WITH NO PATIENT RISK.