Sonicision SCDA13Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521592827), received between Apr 1, 2020 and Jun 26, 2025 — classified as 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 reports).

2 other recalls cover devices cleared under the same FDA submission (K180149); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2025Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A HEMORRHOID SURGERY, THE DEVICE WAS ACTIVATED FOR TRANSECTION OF SOFT TISSUE BUT THE LIGHT TURNED RED. IT HAD A GREEN LIGHT WHEN NOT ACTIVATED AND AFTER THE JAW WAS CLEANED, IT STILL WOULD NOT ACTIVATE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THE DISSECTOR HAD A FRACTURED WAVEGUIDE. THE BROKEN PIECE WAS NOT RETURNED. THE WAVEGUIDE WAS INSPECTED UNDER MAGNIFICATION AND THE ORIGIN OF THE CRACK WAS IDENTIFIED. INVESTIGATION PERSONNEL CONCLUDED THAT THE TITANIUM WAVEGUIDE BECAME CRACKED FROM CONTINUED USE AFTER IT MAY HAVE COME IN CONTACT WITH A METALLIC OBJECT. USE AFTER DAMAGE CAN CAUSE THE CRACKED WAVEGUIDE TO BREAK OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22337699 ↗
• InjuryOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A THYROIDECTOMY PROCEDURE, THE PATIENT HAD A RIGHT COMMON CAROTID ARTERY INJURY, A BRISK ARTERIAL BLEEDING, WHILE DIVIDING THE SUPERIOR POLE. PROXIMAL AND DISTAL CONTROL WAS OBTAINED AND IT WAS ASCERTAINED THAT THERE WAS AN INJURY TO THE COMMON CAROTID ARTERY ON THE RIGHT SIDE. VASCULAR SURGEON PERFORMED AN END-TO-END ANASTOMOSIS OF THE COMMON CAROTID ARTERY. A SURGICAL PROCEDURE WAS PERFORMED DUE TO HEMORRHAGE AND THE PATIENT HAD A PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THE PATIENT RECOVERED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15642483 ↗
• MalfunctionOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE SURGEON TOUCHED INACTIVE BLADE AND BURNED HIS FINGER. A MINOR BURN THROUGH GLOVE. THERE WAS NO TREATMENT PERFORMED. A NEW LIKE DEVICE WAS OPENED AND THE SURGEON CHANGED HIS GLOVES TO COMPLETE THE PROCEDURE.

  Patient problems: Burn(s)

  MAUDE report 15574541 ↗
• InjuryMay 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER TOTAL BILATERAL MODIFIED RADICAL NECK DISSECTION, THE PATIENT HAD CHYLE LEAK. THERE WAS ABOUT 1000CC MILKY OUTPUT FROM JACKSON-PRATT (JP) DRAIN WHICH RESULTED TO HOSPITALIZATION AND WAS TREATED WITH SURGICAL PROCEDURE. REASONS FOR REINTERVENTION WERE LYMPHANGIOGRAM, ASPIRATION AND LYMPHATIC EMBOLIZATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Aspiration/Inhalation

  MAUDE report 14408800 ↗
• MalfunctionOct 11, 2021Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE JAW OF THE DEVICE WAS STUCK IT WOULD NOT OPEN/CLOSE PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12610640 ↗
• InjuryMay 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THERE WAS A HEMORRHAGE TENESMES WITH RED BLOOD EXTERIORIZATION FROM POST SONICISION HEM ORRHOIDS. OTHER DEVICE SUCH MONOPOLAR DEVICE WERE USED IN THE PROCEDURE. THE EVENT LED TO EXTENDED HOSPITALIZATION, BUT IT WAS ASKED BUT UNKNOWN IF THERE WAS A MEDICAL OR SURGICAL INTERVENTION DONE TO PREVENT A PERMANENT IMPAIRMENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11819785 ↗
• InjuryMay 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, TWO DAYS AFTER HEMORRHOIDECTOMY PROCEDURE WITH MORGAN MILLIGAN TECHNIQUE, THE PATIENT H AD BLEEDING WITH RECTAL PAIN AND CRAMPING. THIS EXTENDED THE PATIENT HOSPITALIZATION. IT WAS REPORTED THAT TRANSFUSION WAS NOT NECESSARY. NO FURTHER PATIENT COMPLICATION REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11819740 ↗
• InjuryMay 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER HEMORRHOIDECTOMY WITH MORGAN MILLIGAN TECHNIQUE PROCEDURE, THE PATIENT HAD A HEMORRHAGE. EVERYTHING DID FINE DURING PROCEDURE BUT COMPLICATIONS ARRIVED TWO DAYS AFTER. THE PATIENT HAD TENESMUS WITH RED BLOOD EXTERIORIZATION OR A RECTAL PAIN, CRAMPING AND RECTAL BLEEDING. A LOT OF BLOOD WAS LOST BUT WAS NOT DETERMINED HOW MUCH EXACTLY. TRANSFUSION WAS NOT NECESSARY AND NO SURGICAL OR MEDICAL INTERVENTION NEEDED. PATIENT WAS FINE NOW.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11819576 ↗
• MalfunctionMar 30, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, SMALL PIECES OFF PLASTIC FELL OF THE HANDPIECE. SURGEON IDENTIFIED IT AS BLUE AND WHITE PLASTIC PIECES AND REMOVED BOTH BUT IN THE END OF THE CASE, THE SCRUB TECH COULD NOT LOCATE EITHER PIECE. THE PROCEDURE WAS COMPLETED USING THE SAME HANDPIECE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11590891 ↗
• MalfunctionSep 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE GOT A RED LIGHT, THEN THEY CHANGED THE BATTERY OUT OF FIELD AND THE ACTIVE BLADE WAS BROKEN. A PHOTO WAS ATTACHED SHOWING THE DISSECTOR'S UPPER JAW BROKE OFF WITH THE BROKEN PIECE ON THE SIDE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10540303 ↗
• MalfunctionMay 12, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PRE-OPERATIVE DEMONSTRATION, THE CLINICIAN TRIED THE NEW DEVICE, ACTIVATING FIRST WITH THE JAWS OPEN AND CLOSING THEM. THE HEAT MELTED THE TEFLON AND THE DEVICE DID NOT GIVE ANY ALARM. THE PHOTO SUBMITTED SHOWING THAT THE JAW LINER WAS MELTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10046245 ↗
• MalfunctionApr 1, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A OPEN LIVER RESECTION PROCEDURE, THE DEVICE'S INSULATION ON NON ACTIVE JAW CAME OFF WHILE BEING CLEANED. NOTHING FELL INTO THE PATIENT CAVITY. THEY REPLACED THE DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9912503 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K180149. One submission often covers many models, so check the product and lot details in each record.

• Z-0332-2022 · Nov 12, 2021 · Open, Classified
  Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status Item
• Z-2240-2021 · Jun 23, 2021 · Terminated
  Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade. Product Number: SCGAA