MalfunctionFFN
DEBAKEY RING HANDLE BULLDOG CLAMPS - 45 DEGREE
Received Jul 22, 2010 · Event occurred Jul 1, 2010
Report 1044475-2010-00088 · MDR key 1775272
Device
Generic name
Bulldog Clamps
Manufacturer
Teleflex MedicalModel number
NACatalog number
353189
Lot number
MM1
Product problems
- Difficult to Remove
- Physical Resistance
- Difficult to Open or Close
Patient
Not reported
- No Code Available
Narrative
Description of Event or Problem
THE EVENT IS REPORTED AS: VERY DIFFICULT TO RELEASE AND CLOSE - THERE IS A LOT OF RESISTANCE IN MOVEMENT WHICH HAS CAUSED DAMAGE TO THE PT VESSEL. THE SURGEON REPORTED THAT WHEN HE WAS TRYING TO RELEASE THE RATCHET, IT TORE THE VESSEL IN A CABG PROCEDURE. AFTER INCIDENT, PT CONDITION WAS LISTED AS FINE.
Additional Manufacturer Narrative
PRODUCT HAS NOT YET BEEN RECEIVED BY MFR, THEREFORE, THE INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A F/U INVESTIGATION REPORT WILL BE SENT WHEN INFO BECOMES AVAILABLE.
Remedial action
- Other