MalfunctionFGM
MAYO COMMON DUCT PROBE
Received Dec 9, 1998
Report 1423507-1998-00358 · MDR key 200995
Device
Generic name
Instrument
Manufacturer
Allegiance Healthcare Corp.Model number
SU10910018Catalog number
SU10910018
Lot number
V
Product problems
- Break
- Crack
Patient
UNKNOWN
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
INSTRUMENT CRACKED IN HALF DURING CHOLECYSTECTOMY SURGERY. THE PROBE CRACKED AT ONE OF THE IDENTIFICATION LINES. THE PHYSICIAN HAD THE PROBE IN HIS HAND TO POSITION IT WHEN THE BREAKAGE OCCURRED. THE INSTRUMENT WAS NOT IN THE PT'S BODY; THEREFORE, NO PT INJURY OCCURRED AS A RESULT OF THE BREAKAGE.