OCTOBASE RETRACTOR RACK
Received Jan 7, 2011 · Event occurred Dec 10, 2010
Report 2135394-2011-00003 · MDR key 1971344
Device
Product problems
- Device, removal of (non-implant)
Patient
UNK
- Foreign body, removal of
Narrative
Additional Manufacturer Narrative
(B)(4): ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, VISUAL INSPECTION SHOWED THE RETRACTOR HANDLE WAS BROKEN AND RETURNED IN TWO PIECES. FURTHER INSPECTION SHOWED A BEND IN THE METAL POST. PERFORMANCE TESTING WAS NOT PERFORMED, AS THE UNIT WAS CONSIDERED NON-FUNCTIONAL. CONCLUSION: THE CAUSE FOR THIS EVENT CANNOT BE DETERMINED AT THIS TIME. FURTHER INVESTIGATION IS PENDING. UPON FURTHER INFO, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
MEDTRONIC RECEIVED INFO THAT THE HANDLE OF THE OCTOBASE WAS BEND AND FELL APART WHILE IN THE CHEST OF THE PT. ALL PARTS WERE SUCCESSFULLY RETRIEVED WITH NO ADVERSE PT EFFECTS.