ARTHROCARE STARVAC¿ ARTHROWAND¿, 90 DEGREE, W/INTEGRATED CABLE, SUCTION (GREY)
Received Aug 13, 2018 · Event occurred Jul 17, 2018
Report 3032391-2018-00009 · MDR key 7777241
Device
Generic name
Arthrocare Starvac¿ Arthrowand¿, 90 Degree, W/integrated Cable, Suction (grey)
Manufacturer
Medline RenewalModel number
ASC 4251-01Catalog number
REP103688
Lot number
346724
Product problems
- Break
- Detachment of Device or Device Component
Patient
Not reported
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE TIP OF A REPROCESSED ARTHROCARE WAND FELL APART INSIDE OF A PATIENT DURING USE. PER REPORT, THE PHYSICIAN WAS ABLE TO LOCATE AND SUCCESSFULLY RETRIEVE ALL THE BROKEN PIECES FROM THE PATIENT THROUGH AN UNKNOWN METHOD. THE REPORTING FACILITY STATED THAT THEY WERE ABLE TO GRAB ANOTHER DEVICE AND THE SURGERY COMMENCED WITHOUT FURTHER INCIDENT. THERE WAS NO REPORT OF SERIOUS INJURY, ADVERSE PATIENT CONSEQUENCE OR PROLONGED ANESTHESIA RELATED TO THE INCIDENT. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, RENEWAL IS FILING THIS MEDWATCH REPORT. THE SAMPLE WAS RETURNED FOR EVALUATION AND IT WAS CONFIRMED THAT THE DEVICE WAS REPROCESSED. THE REPORTED ISSUE THAT THE TIP HAD BROKEN OFF OF THE DEVICE WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT THE TIP OF A REPROCESSED ARTHROCARE WAND FELL APART INSIDE OF A PATIENT DURING USE.