inforMED
MalfunctionGAD

FAVALORO-MORSE STERNAL RETRACTOR

Received Oct 29, 2007

Report 2430952-2007-00045 · MDR key 980553

Device

Generic name

Thoracic/cardiovascular

Manufacturer

Rudolf Storz Gmbh

Model number

*

Catalog number

300-253

Lot number

*

Product problems

  • Component Falling
  • Device, removal of (non-implant)

Patient

*

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

THE USER FACILITY REPORTED THAT THE RETRACTOR BLADE FELL INTO PT. THE USER FACILITY COULD NOT DETERMINE WHICH BLADE FELL INTO THE PT; THE DEVICE WAS REC'D AND THERE WAS NO PT INJURY REPORTED.