MalfunctionGDZ
PILLING KNIFE HANDLE
Received Jul 3, 2008
Report 1044475-2008-00020 · MDR key 1069723
Device
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