MalfunctionFFZ
*
Received Apr 11, 2005 · Event occurred Feb 24, 2005
Report 593252 · MDR key 593252
Device
Generic name
Irrigating Bipolar Cord
Manufacturer
Sri/surgical Express, Inc.Model number
ET0858FCatalog number
NOT REPORTED
Lot number
NOT REPORTED
Product problems
- Fitting Problem
Patient
66 YR
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
AN IRRIGATING BIPOLAR CORD FROM THE HARVEST SET WOULD NOT PLUG INTO THE UNIT. THE CORD PLUG JUST KEPT FALLING OUT OF THE HOLES, DESPITE BEING INSERTED ALL THE WAY. ANOTHER CORD WAS ADDED. IT FIT INTO THE SOCKET, BUT NOT TIGHTLY. THE FIT WAS ADEQUATE TO HOLD THE PLUGS IN PLACE WITHOUT INTERVENTION.