MalfunctionGDZ
PILLING KNIFE HANDLE
Received Jul 3, 2008
Report 1044475-2008-00019 · MDR key 1069745
Device
Generic name
Knife Handle
Manufacturer
Teleflex MedicalModel number
NACatalog number
352950
Lot number
PP6 NN6
Product problems
- Loose
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
INCIDENT REPORTED AS: BLADE WILL NOT SIT ONTO HANDLE PROPERLY. NO PATIENT AND/OR USER INJURY. NO INTERVENTION REPORTED.
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.
Remedial action
- Modification/Adjustment