RHOTON BLUNT HOOK-90 DEGREES
Received Mar 22, 2012 · Event occurred Feb 7, 2012
Report 1226348-2012-00153 · MDR key 2500351
Device
Generic name
Dissector, General Purpose
Product problems
- Break
Patient
Not reported
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
MEDWATCH REPORTED THAT THE TIP OF THE MICROSCOPIC RHOTON HOOK BROKE OFF DURING NEUROSURGICAL PROCEDURE. ADDITIONAL INFORMATION EXPLAINED IN A PHONE CONVERSATION WITH THE CUSTOMER SAID, THAT AN XRAY WAS TAKEN AND WAS NEGATIVE. THE PIECE WAS FOUND IN THE SUCTION. DEVICE WAS DISCARDED AND THE PRODUCT CODE IS NOT KNOWN.
Additional Manufacturer Narrative
IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. (B)(4): DEVICE NOT RETURNED.