MalfunctionNLQ
HARMONIC ACE+7 SHEARS 5MM X 36CM
Received Aug 6, 2025 · Event occurred Jul 10, 2025
Report 3032391-2025-00006 · MDR key 22727249
Device
Generic name
Harmonic Ace+7 Shears 5mm X 36cm
Manufacturer
Medline RenewalCatalog number
HARH36RH
Lot number
530916
Product problems
- Material Fragmentation
- Material Fragmentation
Patient
NA · Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
THE TIP OF THE DEVICE FELL APART IN THE ABDOMEN DURING USE.
Additional Manufacturer Narrative
THE TIP OF THE DEVICE FELL APART IN THE ABDOMEN DURING USE. 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.