inforMED
MalfunctionGEJ

SMITH & NEWMAN

Received Apr 23, 2002 · Event occurred Apr 15, 2002

Report MW1024883 · MDR key 392074

Device

Generic name

Hemostatix Thermal Scalpel

Manufacturer

*

Model number

*

Catalog number

70135050

Lot number

0212548258

Product problems

  • Retraction Problem
  • Failure to Calibrate

Patient

57 YR

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

SHAW HANDLE WORKED FOR 1/2 HR THEN STOPPED CALIBRATING. A NEW HANDLE WAS USED.