RUSCH GREENSPEC FO HANDLE, SMALL
Received Aug 12, 2013 · Event occurred Jul 19, 2013
Report 3004365956-2013-00260 · MDR key 3289926
Device
Generic name
Laryngoscope Fo Handle
Manufacturer
Teleflex MedicalCatalog number
004412200
Lot number
02E1302659
Product problems
- Overheating of Device
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
THE COMPLAINT WAS REPORTED AS: THE CUSTOMER ALLEGES THAT THE HANDLE GETS HOT WHEN ATTACHED TO THE LARYNGOSCOPE BLADE. THE ALLEGED DEFECT OCCURRED PRIOR TO PT USE AND DURING PRE-TESTING. NO REPORT OF A PT INJURY.
Additional Manufacturer Narrative
NO VISUAL AND FUNCTIONAL INSPECTION CAN BE PERFORMED SINCE THE DEFECTIVE SAMPLE IS NOT AVAILABLE FOR EVAL. THE DEVICE HISTORY RECORD (DHR) OF BATCH NUMBER 02E1302659 HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. NO NON CONFORMANCE REPORTS WERE ORIGINATED FOR THE LOT IN QUESTION THAT CAN BE ASSOCIATED TO THE COMPLAINT REPORTED. DHR SHOWS THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO OUR SPECIFICATIONS. NO CORRECTIVE ACTION CAN BE ESTABLISHED SINCE THE DEFECTIVE SAMPLE WAS NOT REC'D FOR EVAL. NO CONCLUSION CAN BE ESTABLISHED AT THIS TIME BASED ON THE LACK OF DEFECTIVE OF SAMPLE. IT IS NECESSARY TO HAVE THE PHYSICAL SAMPLE IN ORDER TO PERFORM A PROPERLY INVESTIGATION.