MalfunctionGAD
O'SULLIVAN-O'CONNOR ABDOMINAL RETRACTOR WITH 3
Received Feb 13, 2006
Report 2430952-2006-00005 · MDR key 675917
Device
Generic name
Jarit General Operating Instrument
Manufacturer
Rudolf Storz GmbhModel number
*Catalog number
205-325
Lot number
*
Product problems
- Detachment Of Device Component
- Component Falling
- Use of Device Problem
Patient
UNKNOWN
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED THAT THE FLAT HEAD SCREW FELL OFF DURING A SURGICAL PROCEDURE. NO PT INJURY WAS REPORTED. THIS SCREW IS DESIGNED TO BE REMOVED DURING CLEANING AND MAINTENANCE OF THE INSTRUMENT. VISUAL INSPECTION OF THE INSTRUMENT DID NOT REVEAL ANY DEFECTS.