LIGATURE CLIP 12 MAG.=144 PCS.
Received Aug 24, 2015 · Event occurred Jan 27, 2015
Report 2916714-2015-00758 · MDR key 5044874
Device
Product problems
- Defective Device
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
US REPORTING AGENT NOTIFIED ON: (B)(6)2015. MANUFACTURING SITE EVALUATION: MOUNTING CLIP AT THE BACK IS BROKEN OFF; THE BROKEN FRAGMENT WAS NOT RECEIVED FOR EVALUATION. VISUAL MICROSCOPIC EVALUATION SHOWS THE BREAKAGE SURFACE IS A FORCED FRACTURE DUE TO OVERLOAD. THERE WERE NO PORES, INCLUSIONS, OR FOREIGN BODIES FOUND AT THE POINT OF RUPTURE. MANUFACTURING RECORDS WERE REVIEWED FOR THE REPORTED LOT NUMBER AND NO DEVIATIONS WERE NOTED. THERE HAVE NOT BEEN ANY OTHER COMPLAINTS FOR THIS LOT NUMBER. DAMAGE APPEARS TO BE THE RESULT OF THE END USER, MAY HAVE OCCURED DURING UNPACKING OR DURING INSTALLATION TO THE APPLICATOR. NO CORRECTIVE/PREVENTIVE ACTION IS REQUIRED.
Description of Event or Problem
COUNTRY OF COMPLAINT: (B)(6). BROKEN CARTRIDGE; INCORRECT POSITIONING OF THE CLIP.