RENEWAL
Received Feb 24, 2026 · Event occurred Jan 21, 2026
Report 3032391-2026-00002 · MDR key 24433303
Device
Generic name
Harmonic Ace+7 Shears 5mm X 36cm
Manufacturer
Medline RenewalCatalog number
HARH36RH
Lot number
561906
Product problems
- Connection Problem
Patient
NA · Unknown
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
UPDATE TO D4: EXPIRATION DATE.
Additional Manufacturer Narrative
ACCORDING TO THE CUSTOMER, DURING A "LAPAROSCOPIC HYSTERECTOMY" PROCEDURE ON (B)(6) 2026. THE HARMONIC SHOWED A "MALFUNCTION" AND THE END "FELL OFF INTO ABDOMINAL CAVITY" WHILE RUNNING A "TEST". THE CUSTOMER REPORTED THAT THE END WAS REMOVED FROM THE PATIENT, A NEW HARMONIC WAS USED, AND THERE WAS NO PATIENT INJURY AS A RESULT OF THE REPORTED INCIDENT. 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 COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. 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 CUSTOMER, DURING A "LAPAROSCOPIC HYSTERECTOMY" PROCEDURE ON (B)(6) 2026 THE HARMONIC SHOWED A "MALFUNCTION" AND THE END "FELL OFF INTO ABDOMINAL CAVITY" WHILE RUNNING A "TEST".