Sonicision SCDA26Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10884521592834), received between Jul 20, 2020 and Sep 22, 2026 — classified as 1 injury, 29 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (27 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Detachment of Device or Device Component

  It was reported that, during procedure, the dissector after use, it was placed on the instrument table an a sound was heard. Upon checking it was found that an included metal rod like object had fallen off. There was no component dropped into the abdominal cavity, and there were no issues with use. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50849979 ↗
• MalfunctionSep 21, 2026Failure to Fire; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50849015 ↗
• MalfunctionJun 25, 2026Failure to Fire; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING PROCEDURE, THE DISSECTOR BROKE DURING USE ON A PATIENT AND HAD RED LIGHT. IT WAS WORKING INTERMITTENTLY PRIOR TO DISENGAGEMENT. THE TOP OF THE JAW HAD BROKE AND ALL PIECES WERE RETRIEVED. THERE WAS NO PIECE THAT FALL INTO THE PATIENT CAVITY. THE DEVICE WAS NOT BROKEN DURING CLEANING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25626401 ↗
• MalfunctionJun 8, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE MIDDLE OF THE PROCEDURE, THE DISSECTOR'S TOP OF JAW HAD BROKE DURING USE ON PATIENT. RED LIGHT WAS OBSERVED. THE DEVICE WAS WORKING INTERMITTENTLY PRIOR TO THE DISENGAGEMENT OF THE PIECE. THERE WAS NO ANY PIECE FALL INTO THE PATIENT CAVITY. ALL PIECES WERE RETRIEVED. X-RAY WAS NOT NECESSARY. IT DID NOT BREAK DURING CLEANING. IT WAS REPLACED WITH A NEW DISSECTOR TO COMPLETE THE PROCEDURE. THERE WAS NO ANY ADDITIONAL PROCEDURE NEEDED TO REMOVE THE PIECE FROM THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25428990 ↗
• MalfunctionNov 3, 2025Difficult to Open or Close; Mechanics Altered; Difficult to Open or Close; Mechanics Altered

  IT WAS REPORTED THAT THE SCISSORS DID NOT MEET AND COULD NOT CLOSE. THE DEVICE WAS REPLACED BY OPENING A NEW ONE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23454690 ↗
• MalfunctionOct 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING USE, THE DEVICE STOPPED WORKING. IT WAS ALSO REPORTED THAT THE DEVICE HANDLE WAS BROKEN, THE SPRING IN THE HANDLE EJECTS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23347904 ↗
• MalfunctionAug 26, 2025Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A PROCEDURE, THE DISSECTOR DID NOT ACTIVATE AND CANNOT BE USED AFTER 30 MINUTES OF USE. FLASHING ERROR CANNOT BE CLEARED AND THERE WAS NO VISIBLE DAMAGE TO THE DISSECTOR. A NEW DISSECTOR WAS USED TO COMPLETE THE PROCEDURE. NOTHING FELL ON PATIENT'S CAVITY AND THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE DISSECTOR HAD A FRACTURED WAVEGUIDE. THE BROKEN PIECE WAS RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22892796 ↗
• MalfunctionMay 23, 2025Detachment of Device or Device Component; Difficult to Open or Close; Detachment of Device or Device Component; Difficult to Open or Close

  IT WAS REPORTED THAT THE DEVICE EXPERIENCED ISSUES PRIOR TO USE ON A PATIENT. THE JAWS WERE NOT CLOSING EVEN AFTER COMPRESSING THE GRAB HANDLE. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THE MANDREL CAP WAS BROKEN OFF AND NOT RETURNED. THE JAW LINER WAS MELTED AND THE DEVICE SHOWS EVIDENCE OF USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22079218 ↗
• MalfunctionAug 8, 2024Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE DID NOT ACTIVATE. NO PART OF THE DISSECTOR BROKE, AND NO PIECE FELL INTO THE PATIENT¿S CAVITY. THE PROCEDURE WAS COMPLETED BY OPENING A NEW DISSECTOR. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND TO HAVE A FRACTURED WAVEGUIDE. THE TIP WAS NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19943013 ↗
• MalfunctionAug 5, 2024Failure to Fire; Detachment of Device or Device Component; Naturally Worn; Failure to Fire; Detachment of Device or Device Component; Naturally Worn

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE¿S WHITE PART OF THE JAW HAD MELTED, AND A RED LIGHT ALSO APPEARED ON THE GENERATOR. THE SURGERY WAS COMPLETED SUCCESSFULLY USING LIGASURE. THERE WAS NO PART OF THE DISSECTOR WAS BROKEN OFF. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND A SECTION OF JAW LINER TIPS HAD DETACHED.

  Patient problems: Insufficient Information

  MAUDE report 19907552 ↗
• MalfunctionJul 23, 2024Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN LIVER RESECTION PROCEDURE USING THE DEVICE, AN ERROR OCCURRED AND IT COULD NOT BE USED. AP PROXIMATELY WITHIN ONE HOUR, THE DEVICE STOPPED AND A RED LIGHT WAS OBSERVED. THE TISSUE PAD OF THE DISSECTOR MELTED AND WAS DAMAGED. NO PIECE FELL INTO THE PATIENT¿S CAVITY. THE DISSECTOR WAS REPLACED WITH A NEW ONE, AND THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19809321 ↗
• MalfunctionApr 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THYROIDECTOMY, ACTIVE BLADE BROKE DEEP INTO SURGERY AFTER MULTIPLE ACTIVATIONS. NOTHING FELL INTO PATIENT'S CAVITY. REPLACED WITH NEW DISSECTOR TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19093347 ↗
• MalfunctionApr 4, 2024Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE STOPPED WORKING, ERROR TONES HEARD OR RED LIGHTS OBSERVED. ANOTHER BATTERY INSTALLED ONTO THE HANDPIECE. THE DISSECTOR DID NOT COME INTO CONTACT WITH ANY METAL INSTRUMENTS. ANOTHER DISSECTOR WAS USED WITH THE SAME GENERATOR AND BATTERY AND IT WORKED FINE. THERE WAS NO PATIENT INJURY. 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 19042647 ↗
• MalfunctionMar 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING USE, AT THE MIDDLE OF THE PROCEDURE, THE DISSECTOR'S TIP OF THE FORCEPS DETERIORATED AND TEFLON PARTICLES FELL INTO THE PATIENT'S THORACIC CAVITY. ALL PIECE'S WERE RETRIEVED. REPLACED WITH ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 18852822 ↗
• MalfunctionJan 19, 2024Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC UTERINE FIBROIDS, MIDWAY THE SURGERY THE DISSECTOR STARTED MAKING AN ERROR SOUND AND COULD NO LONGER BE ACTIVATED. WHEN IT WAS REPLACED WITH A NEW DISSECTOR, THE ERROR SOUND DISAPPEARED, AND THE DEVICE COULD BE USED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE DISSECTOR HAD A FRACTURED WAVEGUIDE. THE WAVEGUIDE WAS RETURNED WITH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18548021 ↗
• MalfunctionDec 13, 2023Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE FORCEPS STOPPED WORKING AFTER AN HOUR OF NON-CONTINUOUS USE, THE DEVICE HAD A BROKEN ACTIVE PART THAT WAS COMPLETELY DETACHED, NO DETACHED PART FELL INTO THE PATIENT'S CAVITY. ANOTHER DISSECTOR WAS USED WITH THE SAME GENERATOR AND BATTERY TO COMPLETE THE PROCEDURE AND IT WORKED WELL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18320118 ↗
• MalfunctionNov 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE JAW BROKE DURING USE ON A PATIENT. THE PHOTO OBSERVATION SHOWED THAT THE JAW LINER OF THE DEVICE WAS DETACHED.

  Patient problems: Insufficient Information

  MAUDE report 18196830 ↗
• MalfunctionMay 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE'S TAPER AROUND JAW BREAK OFF. THE DEVICE DID NOT BREAK DURING CLEANING. NO MEDICAL OR SURGICAL INTERVENTION NEEDED. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THEY USED ANOTHER LIKE DEVICE AND IT WORKED FINE. THERE WAS NOTHING FELL INTO PATIENTS CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16993143 ↗
• MalfunctionMar 16, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE TIP COVER OF THE TISSUE PAD CAME OFF AFTER ONLY A FEW TIMES USES, SO AN INITIAL DEFECT WAS SUSPECTED. NO PIECE OF THE DEVICE FELL INTO PATIENT CAVITY. THE PRODUCT WAS REPLACED AND USED. ANALYSIS FOUND THAT THE SECTION OF THE JAW LINER DETACHED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16554031 ↗
• MalfunctionNov 22, 2022Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE OUTPUT WAS POSSIBLE UP TO THE SECOND TIME WHEN THE OPERATION STARTED, BUT WHEN IT WAS USED FOR THE THIRD TIME, AN ERROR SOUND APPEARED AND IT BECAME UNUSABLE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE DISSECTOR HAD A FRACTURED WAVEGUIDE BUT THE TIP WAS RETURNED. USED A SAME DEVICE AND IT WORKED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15845566 ↗
• MalfunctionNov 16, 2022Failure to Deliver Energy; Failure to Cut; Failure to Fire; Detachment of Device or Device Component; Failure to Deliver Energy; Failure to Cut; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, AFTER 40MINUTES OF SURGERY, A RED LIGHT AND SEVERAL TONES APPEARED, THEN THE DEVICE STOPPED WORKING, NOTHING HAPPEN, NO COAGULATION AND NO CUT. TOOK ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15809565 ↗
• MalfunctionAug 18, 2022Intermittent Energy Output; Intermittent Energy Output

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE DID NOT ACTIVATE. BASED ON THE INVESTIGATION, THE TITANIUM WAVEGUIDE WAS IN USE WHEN IT FRACTURED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15250706 ↗
• InjuryAug 11, 2022Detachment 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. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THE DISSECTOR HAD A FRACTURED AND DETACHED WAVEGUIDE. THE WAVEGUIDE WAS NOT RETURNED. THE DEVICE SHOWED EVIDENCE OF USE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15211407 ↗
• MalfunctionJul 27, 2022Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE STOPPED WORKING. ANOTHER BATTERY WAS INSTALLED ONTO THE HANDPIECE. ERROR TONES WERE HEARD OR RED LIGHTS WERE OBSERVED. NOTHING COMPLETELY BROKE OFF FROM THE DEVICE. ANOTHER DEVICE WAS USED AND WORKED FINE. BASED ON THE INVESTIGATION, THE MANDREL CAP HAD SLIGHTLY CRACKED AND HAD DISENGAGED. THE SPRING HAD ALSO DISENGAGED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15113372 ↗
• MalfunctionMar 31, 2022Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DISSECTOR TURNED RED AND ACTIVATION WAS IMPOSSIBLE. THEY CHANGED INTO ANOTHER DISSECTOR AND IT WORKED FINE. THERE WAS NO PATIENT INJURY. 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 13971520 ↗

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