STONETOME STONE REMOVAL DEVICE
Received Mar 25, 2009
Report 3005099803-2009-01354 · MDR key 1414735
Device
Product problems
- Electrical /Electronic Property Problem
Patient
NA
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
NOTE: THE DATE OF EVENT IS UNK. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2009, THAT A STONETOME STONE REMOVAL DEVICE WAS USED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE COULD NOT BE TURNED ON. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SECOND STONETOME STONE REMOVAL DEVICE. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "GOOD."
Additional Manufacturer Narrative
THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFO IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.