MalfunctionGDR
GIGLI WIRE SAW FINE6-WIRES400MM SAW
Received Aug 21, 2015
Report 2916714-2015-00737 · MDR key 5032831
Device
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.
Description of Event or Problem
COUNTRY OF COMPLAINT: (B)(6). DURING A PROCEDURE, THE HANDLE LOOP DETACHED FROM ONE END OF BOTH GIGLI SAWS 40 CM. TO CONCLUDE THE PROCEDURE, 2 X 30 CM GIGLI SAWS WERE USED BUT THEY ALSO CAME APART AT THE HANDLE LOOP. THESE INSTRUMENTS ARE REPLACED AFTER EACH USE. TWO DEVICES USED IN THIS PROCEDURE WERE REPORTED UNDER MEDWATCH 2916714-2015-00519 AND 2916714-2015-00520.