Medline
Received Mar 10, 2023 · Event occurred Feb 16, 2023
Report 3032391-2023-00002 · MDR key 16525033
Device
Generic name
Asha 4250-01 Ambient Arthrow Super Tur
Manufacturer
Medline RenewalModel number
ASHA42500RHCatalog number
ASHA42500RH
Product problems
- Material Integrity Problem
- Material Integrity Problem
Patient
Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
ACCORDING TO THE CUSTOMER ON (B)(6) 2023 THE ABLATION WAND WAS FLAKING OFF INSIDE THE PATIENT DURING A SURGICAL PROCEDURE.
Additional Manufacturer Narrative
ACCORDING TO THE CUSTOMER ON (B)(6) 2023 THE ABLATION WAND WAS FLAKING OFF INSIDE THE PATIENT DURING A SURGICAL PROCEDURE. PER THE FACILITY THE INCIDENT OCCURRED "ABOUT 45 MINUTES" INTO THE DEVICE BEING USED. PER THE FACILITY "THE SURGEON TOOK THE BURR AND REMOVED THE FLAKES AND FINISHED THE CASE WITH THE SAME DEVICE". NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE SAMPLE WAS RETURNED FOR EVALUATION AND THE REPORTED ISSUE COULD NOT BE CONFIRMED, THEREFORE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.