HARMONIC ACE+7 SHEARS 5MM X 36CM
Received Mar 13, 2025 · Event occurred Feb 13, 2025
Report 3032391-2025-00002 · MDR key 21594634
Device
Generic name
Harmonic Ace+7 Shears 5mm X 36cm
Manufacturer
Medline RenewalCatalog number
HARH36RH
Lot number
527760, 528328
Product problems
- Break
- Break
Patient
NA · Unknown
- Burn(s)
- Foreign Body In Patient
- Burn(s)
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
UPDATE TO H6: INVESTIGATION FINDINGS. UPDATE TO H6: INVESTIGATION CONCLUSIONS.
Additional Manufacturer Narrative
ACCORDING TO THE CUSTOMER, THE HARMONIC SHEARS "BROKE AND BURNT UP INSIDE PATIENT". NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE. DESPITE MULTIPLE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER CONTACT WAS UNABLE OR UNWILLING TO PROVIDE FURTHER INCIDENT DETAILS TO THE MANUFACTURER. NO ADDITIONAL INFORMATION IS AVAILABLE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY, THEREFORE, 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 CUSTOMER, THE HARMONIC SHEARS "BROKE AND BURNT UP INSIDE PATIENT".