HARMONIC ACE+7 SHEARS 5MM X 36CM
Received Jul 20, 2022 · Event occurred Jun 21, 2022
Report 3032391-2022-00006 · MDR key 15070242
Device
Generic name
Harmonic Ace+7 Shears 5mm X 36cm
Manufacturer
Medline RenewalCatalog number
HARH36RH
Lot number
469971
Product problems
- Melted
- Detachment of Device or Device Component
Patient
63 YR · Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
ACCORDING TO THE FACILITY DURING A PROCEDURE 'A WHITE PIECE CAME OFF THE HARMONIC SCALPEL AND MELTED INSIDE THE PATIENT'. PER THE FACILITY THE EVENT HAPPENED DURING THE 'MIDDLE TO END' OF THE PROCEDURE, AND THE PIECE WAS UNABLE TO BE RETRIEVED. ACCORDING TO THE FACILITY, THEY REPORTED THAT THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORTED SERIOUS INJURY OR MEDICAL INTERVENTION NOTED. THE DEVICE IS AVAILABLE BUT HAS NOT BEEN RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE. DUE TO THE REPORTED INCIDENT AND 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 DURING A PROCEDURE 'A WHITE PIECE CAME OFF THE HARMONIC SCALPEL AND MELTED INSIDE THE PATIENT'.