Sonicision SCDA39Recalls & reported problems

Summary

The FDA's MAUDE database contains 355 adverse event reports that list this exact device (DI 10884521592841), received between Sep 16, 2019 and Sep 30, 2026 — classified as 1 death, 28 injuries, 326 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (285 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 355 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949235 ↗
• MalfunctionSep 30, 2026Detachment of Device or Device Component

  It was reported that, during procedure, the doctor noted that the device had been weakened and the tip ended up breaking off while tissue was being dissected. There was no patient harm/injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948237 ↗
• MalfunctionSep 29, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940807 ↗
• MalfunctionSep 25, 2026Failure to Deliver Energy; Peeled/Delaminated; Failure to Cut; Detachment of Device or Device Component

  It was reported that, during procedure, the device presented a defect in cut and coagulation and the Teflon presented failure detaching from the jaws of the device. The device was immediately replaced. There was no patient harm/injury. Photo observation showed the jaw liner sliding midway of the jaw. Medtronic's initial evaluation of the incident device found the jaw liner was removed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903722 ↗
• MalfunctionSep 25, 2026Failure to Fire; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903703 ↗
• MalfunctionSep 25, 2026Failure to Fire; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903110 ↗
• MalfunctionSep 25, 2026Peeled/Delaminated; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902901 ↗
• MalfunctionAug 28, 2026Detachment of Device or Device Component; Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50494251 ↗
• MalfunctionMar 25, 2026Failure to Fire; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PROCEDURE, AFTER APPROXIMATELY 20 MINUTES OF FUNCTIONING THE DEVICE HAD A RED LIGHT. THE BATTERY AND GENERATOR WERE REPLACED BUT THE ISSUE REMAINED. ANOTHER DISSECTOR WAS USED WITH THE SAME GENERATOR AND THE SAME BATTERY AND IT WORKED FINE. THE DISSECTOR DID NOT COME INTO CONTACT WITH ANY METAL INSTRUMENTS. NO PART OF THE DISSECTOR BROKE OR DETACHED. THE CHARGER WAS NOT WORKING AS WELL AND THE INDICATOR LIGHTS ON THE CHARGER WAS RED. THE SAME BATTERY WAS ABLE TO BE CHARGED IN A DIFFERENT BAY. THERE WAS NO PATIENT HARM/INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE DISSECTOR HAD A BROKEN WAVEGUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24686708 ↗
• MalfunctionMar 16, 2026Failure to Fire; Detachment of Device or Device Component

  IT WAS REPORTED THAT ABOUT 20 MINUTES DURING A PROCEDURE, THERE WERE ISSUES WITH THE DISSECTOR AND GENERATOR, INCLUDING FREQUENT RED LIGHT INDICATORS AND THE DEVICE CANNOT BE USED NORMALLY. THERE WERE NO DETACHED PART NOTED. AFTER REPLACEMENT OF THE BLADE, THE SAME ISSUE PERSISTED. THE PROBLEM WAS RESOLVED AFTER REPLACING BOTH THE BLADE AND THE GENERATOR, AND NORMAL FUNCTION WAS RESTORED. NOTHING FELL ON PATIENT'S CAVITY AND THERE WERE NO INTERVENTIONS PERFORMED DUE TO THE ISSUE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE SPRING AND MANDREL CAP HAD DISENGAGED FROM ONE OF THE DISSECTORS AND WERE NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24604364 ↗
• MalfunctionMar 13, 2026Failure to Fire; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, EIGHT DISSECTORS HAD FREQUENT ALARM AND STILL ALARMS AFTER WIPING AND RINSING. SAME SITUATION WHEN CHANGING THE SECOND BLADE. THE SURGEON SWITCHED TO ANOTHER MANUFACTURER. THE DISSECTOR DID NOT BREAK. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE DEVICE'S JAW DISENGAGED, THE BROKEN JAW WAS RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24590688 ↗
• MalfunctionMar 12, 2026Failure to Fire; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PROCEDURE, AFTER ABOUT 10 MINUTES THE DEVICE PRESENTED A RED LIGHT. THE SURGEON CLEANED AND RE-ASSEMBLED BUT WITHOUT SUCCESS. ANOTHER DISSECTOR WAS USED WITH THE SAME GENERATOR AND BATTERY AND IT WORKED NORMALLY DURING THE REST OF THE CASE. NO DETACHED PIECE FELL INTO THE PATIENT'S CAVITY. THERE WAS NO PATIENT HARM/INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE DISSECTOR HAS A DAMAGED WAVEGUIDE. THE WAVEGUIDE TIP WAS FRACTURED AND NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24586934 ↗
• MalfunctionMar 9, 2026Difficult to Open or Close

  IT WAS REPORTED THAT PRIOR TO USE, THE DEVICE'S JAW WAS NOT OPENING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24554443 ↗
• MalfunctionFeb 27, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING MOBILIZATION OF FUNDOPLICATION SURGERY, THE DISSECTOR'S ACTIVE BLADE HAD BROKEN OFF WHEN THE BRANCHES WERE OPEN. THE TEAM REACTED IMMEDIATELY. THE BLADE WAS VISIBLE TO BE LOCATED AND REMOVED FROM THE PATIENT. X-RAY WAS NOT NECESSARY. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE DEVICE DID NOT BREAK DURING CLEANING. THE FALLEN BLADE WAS FIXED TO THE INSTRUMENT HANDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470411 ↗
• MalfunctionFeb 23, 2026Failure to Fire; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING ENDOMETRIOSIS, AFTER 1 HOUR OF USE THE DISSECTOR HAD STOPPED WORKING DURING PROCEDURE. WHEN THE TRIGGER WAS ACTIVATED, IT DID NOT PERFORM ITS FUNCTION. FOLLOWING THE MANUFACTURER'S GUIDELINES THE BATTERY AND GENERATOR WAS CHANGED BUT IT DID NOT WORK. IT WAS NECESSARY TO CHANGE THE DISSECTOR TO FINISH THE PROCEDURE. THE DISSECTOR DID NOT BREAK. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE DISSECTOR HAD A FRACTURED WAVEGUIDE AND THE BROKEN PIECE WAS NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24414591 ↗
• MalfunctionJan 22, 2026Difficult or Delayed Activation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PROCEDURE, THE DISSECTOR WAS DIFFICULT TO ACTIVATE. 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. THE BROKEN PIECE WAS NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24142090 ↗
• MalfunctionJan 8, 2026Self-Activation or Keying; Failure to Fire

  IT WAS REPORTED THAT DURING PROCEDURE, THE DISSECTOR HAD ACTIVATED BY ITSELF AND THEN WOULD NOT ACTIVATE. ANOTHER DISSECTOR WAS USED WITH THE SAME GENERATOR AND BATTERY AND IT WORKED FINE. THE DISSECTOR DID NOT BREAK. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24009781 ↗
• MalfunctionJan 8, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING PROCEDURE, THE DISSECTOR'S JAW HAD SLIPPED INTO THE SHAFT DURING USE. TO DETERMINE WHETHER ANY PART HAD FALLEN INTO THE PATIENT CAVITY, THE SURGEON LATER OPENED THE SHAFT USING A HAND INSTRUMENT AND CHECKED THAT ALL JAW COMPONENTS WERE INSIDE THE SHAFT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24004530 ↗
• MalfunctionJan 6, 2026Device Difficult to Setup or Prepare; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING PROCEDURE, THE DISSECTOR WAS USED FOR THE FIRST TIME, AND WHEN ASSEMBLED, THE SPRING CAME OFF BECAUSE IT DID NOT FIT PROPERLY. THE PIECE DID NOT FALL INSIDE THE PATIENT'S CAVITY. A DIFFERENT DISSECTOR WAS USED WITH THE SAME GENERATOR AND BATTERY, AND IT FUNCTIONED NORMALLY.

  Patient problems: Insufficient Information

  MAUDE report 23973980 ↗
• MalfunctionJan 5, 2026Device Difficult to Setup or Prepare; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING PROCEDURE, THE DISSECTOR WAS USED FOR THE FIRST TIME, AND WHEN ASSEMBLED, THE SPRING CAME OFF BECAUSE IT DID NOT FIT PROPERLY. A DIFFERENT DISSECTOR WAS USED WITH THE SAME GENERATOR AND BATTERY, AND IT FUNCTIONED NORMALLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23956528 ↗
• MalfunctionDec 15, 2025Difficult or Delayed Activation; Detachment of Device or Device Component; Difficult or Delayed Activation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PROCEDURE, THE DISSECTOR WORKED FINE AT FIRST, THEN INTERMITTENTLY AND AFTER 5 MINUTES WHEN THE DISSECTOR WAS REMOVED FROM THE CAVITY, THEY NOTICED THE DISSECTOR'S TIP WAS FRACTURED. A RED LIGHT WAS OBSERVED WHEN THE ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED USING A LAPAROSCOPIC L-HOOK. NOTHING FELL ON PATIENT'S CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23802920 ↗
• MalfunctionDec 11, 2025Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE USING THE DEVICE, THE FORCEPS STOPPED WORKING AFTER APPROXIMATELY 1 HOUR AND 30 MINUTES OF SURGERY. NO PART OF THE DISSECTOR BROKE. A NEW DISSECTOR WAS USED AND IT WORKED FINE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE SPRINGS HAD DISENGAGED FROM THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23783634 ↗
• MalfunctionNov 13, 2025Difficult or Delayed Activation; Detachment of Device or Device Component; Naturally Worn; Difficult or Delayed Activation; Detachment of Device or Device Component; Naturally Worn

  IT WAS REPORTED THAT AT THE BEGINNING OF THE OPERATION, WHEN THE ULTRASONIC DISSECTOR WAS USED TO COAGULATE THE SMALL BLOOD VESSELS AT THE ADHESION BETWEEN THE LUNG AND THE CHEST WALL, THE BLADE¿S INSULATION LAYER HAD DETACHED AND WAS CHARRED. THERE WAS NO PATIENT INJURY AND NOTHING FELL ON THE PATIENT¿S CAVITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544121 ↗
• MalfunctionNov 13, 2025Difficult or Delayed Activation; Detachment of Device or Device Component; Naturally Worn; Difficult or Delayed Activation; Detachment of Device or Device Component; Naturally Worn

  IT WAS REPORTED THAT AT THE BEGINNING OF THE OPERATION, WHEN THE ULTRASONIC DISSECTOR WAS USED TO COAGULATE THE SMALL BLOOD VESSELS AT THE ADHESION BETWEEN THE LUNG AND THE CHEST WALL, THE BLADE¿S INSULATION LAYER HAD DETACHED AND WAS CHARRED. THERE WAS NO PATIENT INJURY AND NOTHING FELL ON THE PATIENT¿S CAVITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544063 ↗
• MalfunctionOct 30, 2025Failure to Cut; Failure to Fire; Detachment of Device or Device Component; Failure to Cut; Failure to Fire; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING PROCEDURE, THE DISSECTOR HAD STOPPED WORKING. DEVICE HAD STOPPED CUTTING ABILITY JUST ON THE BEGINNING OF THE CASE WAS DETECTED. 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. THE DISSECTOR DID NOT BREAK. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THE DISSECTOR HAD A FRACTURED WAVEGUIDE. THE BROKEN PIECE WAS NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23432648 ↗

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