HARMONIC ACE+7 SHEARS 5MM X 36CM
Received Feb 15, 2024 · Event occurred Jan 19, 2024
Report 3032391-2024-00002 · MDR key 18712161
Device
Generic name
Harmonic Ace+7 Shears 5mm X 36cm
Manufacturer
Medline RenewalCatalog number
HARH36RH
Lot number
495994
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
NA · Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
ACCORDING TO THE FACILITY ON 1/19/24 DURING A PROCEDURE THEY NOTICED THAT THE TIP OF THE HARMONIC SHEAR WAS HANGING OFF AND AS THEY WENT TO REMOVE THE DEVICE THE TIP FELL OFF INSIDE OF THE PATIENT. PER THE FACILITY THEY WERE ABLE TO LOCATE THE FOREIGN BODY "AFTER SOME TIME". NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE SAMPLE WAS REQUESTED FOR EVALUATION. 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.
Description of Event or Problem
ACCORDING TO THE FACILITY ON 1/19/24 DURING A PROCEDURE THEY NOTICED THAT THE TIP OF THE HARMONIC SHEAR WAS HANGING OFF AND AS THEY WENT TO REMOVE THE DEVICE THE TIP FELL OFF INSIDE OF THE PATIENT.