Sonicision 7 SCD7A13Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521794771), received between Feb 8, 2023 and Jun 9, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2025Failure to Deliver Energy; Failure to Align; Detachment of Device or Device Component; Failure to Deliver Energy; Failure to Align; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN OVARIECTOMY AT A VETERINARY CLINIC, THE DISTAL PART OF THE DISSECTOR'S JAW DID NOT CLOSE COMPLETELY, LEAVING A SMALL GAP OF APPROXIMATELY 1 MILLIMETER BETWEEN THE JAWS. ADDITIONALLY, THE DEVICE DID NOT COAGULATE EFFECTIVELY IN THE MIDDLE OF THE JAW. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE JAW LINER WAS MELTED AND PARTIALLY DISLODGED. THERE WERE ALSO MISSING PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22169252 ↗
• MalfunctionMay 15, 2025Peeled/Delaminated; Detachment of Device or Device Component; Naturally Worn; Peeled/Delaminated; Detachment of Device or Device Component; Naturally Worn

  ACCORDING TO THE REPORTER, DURING A PYOMETRA PROCEDURE ON A VETERINARY CASE, THE SEAL IN THE JAW WAS BURNED AND THE COATING ON THE DISSECTOR BEGAN TO PEEL OFF. THERE WAS NO PIECE FELL INTO THE CAVITY. DESPITE THIS, THE BLOOD VESSELS AND TISSUE WERE SUCCESSFULLY SEALED AND COAGULATED. HOWEVER, THE VETERINARIAN LOST CONFIDENCE IN THE DEVICE AND IMMEDIATELY SWITCHED TO USING SUTURE. AT THAT POINT, BOTH OVARIES AND ONE SIDE OF THE CERVIX HAD ALREADY BEEN SEALED, WITH NO ACTIVE BLEEDING OBSERVED. THE FINAL VESSEL ON THE CERVIX WAS TIED OFF WITH SUTURE. AFTER CLOSING THE ANIMAL AND TRANSFERRING IT TO RECOVERY, HOSPITALIZATION WAS EXTENDED FOR ONE DAY AND A SUBSEQUENT CHECK REVEALED THAT THE ANIMAL HAD PASSED AWAY. PRELIMINARY FINDINGS OF THE AUTOPSY INDICATED INTERNAL BLEEDING AS THE CAUSE OF DEATH, THOUGH THE EXACT SOURCE REMAINS UNCLEAR. A PHOTO WAS SUBMITTED SHOWING THE JAW LINER WAS MELTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22026730 ↗
• MalfunctionJan 28, 2025Detachment of Device or Device Component; Intermittent Energy Output; Detachment of Device or Device Component; Intermittent Energy Output

  ACCORDING TO THE REPORTER PRIOR TO USE, THE DEVICE DID NOT ACTIVATE. USED ANOTHER DISSECTOR AND IT WORKED FINE. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE DISSECTOR HAD A FRACTURED WAVEGUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21252173 ↗
• InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A THYROIDECTOMY, THE DEVICE GOT HOT AND BURNED THE PATIENT'S CAROTID ARTERY AND NEEDED TO BE TRANSFERRED TO ANOTHER FACILITY FOR OBSERVATION. THE PATIENT WAS IN A CRITICAL CARE/INTENSIVE CARE UNIT (ICU) SETTING.

  Patient problems: Burn(s)

  MAUDE report 17238126 ↗
• InjuryFeb 8, 2023Failure to Deliver Energy; Overheating of Device; Adverse Event Without Identified Device or Use Problem; Failure to Deliver Energy; Overheating of Device; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THYROIDECTOMY, THE DEVICE TAKES 30-40% LONGER TO OCCLUDE VESSELS IN MIN MODE AND RESULTED IN NERVE DAMAGE BECAUSE THE DEVICE GETS HOTTER.

  Patient problems: Nerve Damage

  MAUDE report 16326976 ↗