HARMONIC ACE+7 SHEARS 5MM X 36CM
Received Jun 13, 2022 · Event occurred May 10, 2022
Report 3032391-2022-00004 · MDR key 14680796
Device
Generic name
Harmonic Ace+7 Shears 5mm X 36cm
Manufacturer
Medline RenewalCatalog number
HARH36RH
Lot number
464240
Product problems
- Break
Patient
45 YR · Female
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT A REPROCESSED HARMONIC SCALPEL PIECE BROKE INSIDE OF THE PATIENT. REPORTEDLY THE CLINICIAN WAS ABLE TO RECOVER THE BROKEN PIECE. NO ADDITIONAL INFORMATION WAS PROVIDED. THE SAMPLE WAS RECEIVED BUT THE ROOT CAUSE COULD NOT DETERMINED. 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
IT WAS REPORTED THAT A REPROCESSED HARMONIC PIECE BROKE INSIDE OF THE PATIENT AND NEEDED TO BE RETRIEVED.