MalfunctionGDR
GIGLI WIRE SAW FINE 6-WIRES500MM
Received Jul 30, 2015
Report 2916714-2015-00651 · MDR key 4963922
Device
Generic name
Cranial Saw
Manufacturer
Aesculap AgModel number
FH415Catalog number
FH415
Lot number
52118162
Product problems
- Material Disintegration
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
U.S. REPORTING AGENT NOTIFIED ON: (B)(6) 2015. MANUFACTURING SITE EVALUATION.
Description of Event or Problem
COUNTRY OF COMPLAINT: (B)(6). INADEQUATE QUALITY OF THE MATERIAL DURING FIRST USE. METAL SHAVINGS LEFT IN THE WOUND, WHICH CAUSED ARTIFACTS DURING EXAMINATION.