MalfunctionFZP
SHAFT COMPL. D:10MM L:370 MM
Received Mar 27, 2015
Report 2916714-2015-00244 · MDR key 4647821
Device
Product problems
- Defective Device
Patient
Not reported
- No Code Available
Narrative
Description of Event or Problem
COUNTRY OF COMPLAINT: (B)(6). SHARP EDGES CAUSED DAMAGE TO BLOOD VESSEL.
Additional Manufacturer Narrative
US. REPORTING AGENT NOTIFIED ON: (B)(4) 2015. MANUFACTURING SITE EVALUATION: THE JAW OF THE RECEIVED DEVICE IS DAMAGED. THIS FAILURE WAS CAUSED BY FALLING/DROP DOWN OF THE INSTRUMENT. THERE ARE INDICATIONS OF MATERIAL OR PRODUCT DEVIATIONS. FAILURE IS USER RELATED.