HARMONIC ACE+7 SHEARS 5MM X 36CM
Received Oct 14, 2021 · Event occurred Oct 1, 2021
Report 3032391-2021-00017 · MDR key 12634450
Device
Generic name
Harmonic Ace+7 Shears 5mm X 36cm
Manufacturer
Medline RenewalCatalog number
HARH36RH
Lot number
V9551L
Product problems
- Break
Patient
Not reported
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE LOWER FOOT OF THE HARMONIC SHEAR DEVICE BROKE OFF IN THE MIDDLE OF AN UNSPECIFIED SURGICAL PROCEDURE AND THE SURGEON WAS UNABLE TO LOCATE THE PIECE OF THE DEVICE. THE SURGEON REPORTEDLY SEARCHED THE FIELD AD IRRIGATED THE ABDOMEN WITHOUT SUCCESS. THE LOWER FOOT WAS NOT LOCATED OR RETRIEVED. THERE WAS NO KNOWN IMPACT TO THE PATIENT OR THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THE HARMONIC SHEAR DEVICE WAS NOT RETURNED FOR EVALUATION. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED. THE END USER FACILITY STATED "THIS WAS REPORTED TO THE FDA, REPORT # (B)(4)."
Description of Event or Problem
IT WAS REPORTED THAT THE LOWER FOOT OF THE HARMONIC SHEAR DEVICE BROKE OFF IN THE MIDDLE OF AN UNSPECIFIED SURGICAL PROCEDURE AND THE SURGEON WAS UNABLE TO LOCATE THE PIECE OF THE DEVICE.