MalfunctionGCF
*
Received Dec 7, 2009 · Event occurred Nov 24, 2009
Report 1561280 · MDR key 1561280
Device
Generic name
Introducer For Rigid Proctoscope
Manufacturer
Bk Medical Systems, Inc.Model number
*Catalog number
*
Lot number
*
Product problems
- Material Separation
Patient
69 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE TIP OF THE INTRODUCER AND HANDLE CAME APART AT ENDS WHERE THEY ARE WELDED. NO HARM OCCURRED TO THE PATIENT.