inforMED
MalfunctionGDZ

PILLING KNIFE HANDLE

Received Jul 3, 2008

Report 1044475-2008-00020 · MDR key 1069723

Device

Generic name

Knife Handle

Manufacturer

Teleflex Medical

Catalog number

352950

Lot number

TT7(6)

Product problems

  • Failure to Deliver

Patient

Not reported

  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

INVESTIGATION REVEALED THAT A TOLERANCE STACK-UP CONDITION COULD PRODUCE INTERFERENCE FIT BETWEEN BLADE AND HANDLE. A CORRECTIVE ACTION WAS IMPLEMENTED AND REVISIONS TO THE DRAWINGS AND MANUFACTURED PARTS WAS COMPLETED.

Description of Event or Problem

INCIDENT REPORTED AS: THE NURSES ARE UNABLE TO LOAD BLADES UNTO KNIFE HANDLES. NO PATIENT OR STAFF INJURY REPORTED. NO INTERVENTION REPORTED.

Remedial action

  • Modification/Adjustment