MalfunctionJCA
TENDERFOOT DEVICE 1000/CS
Received Nov 1, 2011
Report 2250033-2011-00028 · MDR key 2337025
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Product code (JCA)
Model (TF1000I)
Device
Product problems
- Retraction Problem
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
ITC SALES REP REPORTS THAT THE DEMO KIT BLADE ON HER TENDERFOOT DEVICE DID NOT FULLY RETRACT. NO REPORT OF INJURY. NO ADVERSE EVENT(S) REPORTED.
Additional Manufacturer Narrative
(B)(4). RESULT - NO OTHER COMPLAINTS RECEIVED FOR THIS LOT. A SEARCH OF COMPLAINTS FOR THE PAST 1 YEAR INDICATED NO OTHER CASES OF FAILURE TO RETRACT. CONCLUSION - DEVICE EXPECTED TO RETURN TO ITC FOR EVAL. EVAL OF RETAIN SAMPLES FOR SAME LOT PERFORMED ACCORDING TO SPECS.