Sonicision SCD391 (UDI 10884521052659)Recalls & reported problems

Summary

The FDA's MAUDE database contains 188 adverse event reports that list this exact device (DI 10884521052659), received between Aug 2, 2016 and Jan 10, 2025 — classified as 11 injuries, 177 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (83 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 188 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2025Detachment of Device or Device Component; Intermittent Energy Output; Detachment of Device or Device Component; Intermittent Energy Output

  ACCORDING TO THE REPORTER, THE DISSECTOR STOPPED WORKING. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE TIP OF THE WAVEGUIDE HAD FRACTURED AND DISENGAGED. THE BROKEN PIECE WAS RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21130660 ↗
• MalfunctionFeb 20, 2024Device Damaged Prior to Use; Detachment of Device or Device Component; Device Damaged Prior to Use; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE BROKE PRIOR TO USE ON A PATIENT. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT VISUAL INSPECTION OF THE DISPOSABLE DEVICE REVEALED THAT THE TIP OF THE WAVEGUIDE HAD FRACTURED AND DISENGAGED. THE BROKEN PIECE WAS RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18737883 ↗
• MalfunctionMay 15, 2023Break; Difficult or Delayed Activation; Detachment of Device or Device Component; Break; Difficult or Delayed Activation; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ABDOMINAL MASS RESECTION, THE TIP/TOP OF THE JAW OF THE DEVICE HAD DAMAGE MARK AND THE DEVICE WAS WORKING INTERMITTENTLY, NO COMPONENT OF THE DEVICE BROKE OFF, NO RED LIGHT WAS OBSERVED, AND THE DISSECTOR DID NOT CAME IN CONTACT WITH ANY METALLIC INSTRUMENT OR OBJECT. A NEW BLADE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE TIP OF THE WAVEGUIDE HAD FRACTURED AND DISENGAGED. THE BROKEN PIECE WAS RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16936154 ↗
• MalfunctionMar 27, 2023Detachment 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. A NEW DISSECTOR WITH SAME BATTERY AND GENERATOR WORKED FINE. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE TIP OF THE WAVEGUIDE HAD FRACTURED AND DISENGAGED. THE BROKEN PIECE WAS RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16619491 ↗
• MalfunctionFeb 28, 2023Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC MYOMECTOMY, WHILE USING THE 39CM SONICISION DEVICE ONE OF THE TIP BROKE AND A CHART OF THE TIP WAS LEFT INSIDE. THE SURGEON HAVE TO SEARCH FOR THE CHART. IT CAN BE A CAUSE OF INFECTION, IF PARTS OF THE BROKEN TIP WAS LEFT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16452222 ↗
• InjuryJan 6, 2023Difficult or Delayed Activation; Detachment of Device or Device Component; Difficult or Delayed Activation; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DISSECTOR WAS DIFFICULT TO ACTIVATE. ANOTHER DISSECTOR 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 TIP OF THE WAVEGUIDE HAD FRACTURED AND DISENGAGED. THE BROKEN PIECE WAS NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16117290 ↗
• MalfunctionJan 3, 2023Difficult or Delayed Activation; Detachment of Device or Device Component; Difficult or Delayed Activation; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, DEVICE WAS DIFFICULT TO ACTIVATE. A NEW DISSECTOR 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 THE DISPOSABLE DEVICE REVEALED THAT THE TIP OF THE WAVEGUIDE HAD FRACTURED AND DISENGAGED. THE BROKEN PIECE WAS RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16090148 ↗
• MalfunctionDec 20, 2022Difficult or Delayed Activation; Detachment of Device or Device Component; Difficult or Delayed Activation; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE WAS DIFFICULT TO ACTIVATE, THERE WAS A NEW DISSECTOR USED WITH THE SAME GENERATOR AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16014675 ↗
• MalfunctionNov 8, 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 DID NOT ACTIVATE. A NEW/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 TIP OF THE WAVEGUIDE HAD FRACTURED AND DISENGAGED BUT THE BROKEN PIECE WAS RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15752790 ↗
• MalfunctionOct 6, 2022Device Difficult to Setup or Prepare; Detachment of Device or Device Component; Intermittent Energy Output; Device Difficult to Setup or Prepare; Detachment of Device or Device Component; Intermittent Energy Output

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, AFTER THE DEVICE WAS INSTALLED, THE RED LIGHT ON THE GENERATOR ALERTED. THEY DISASSEMBLED IT TO INSPECT, BUT IT WAS DIFFICULT TO DISASSEMBLE. AFTER REMOVING THE DISSECTOR WITH PLIERS, THE STERILE STATED IF THE DISSECTOR WAS DESTROYED AND THE DISSECTOR COULD NOT BE DISINFECTED AGAIN. THE MEDTRONIC INITIAL INVESTIGATION STATED THAT THE WAVEGUIDE HAD FRACTURED. THE FRAGMENT WAS NOT RETURNED WITH THE DEVICE. THE DEVICE WAS USED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15554972 ↗
• MalfunctionAug 30, 2022Difficult or Delayed Activation; Detachment of Device or Device Component; Difficult or Delayed Activation; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE WAS DIFFICULT TO ACTIVATE. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THE TIP OF THE WAVEGUIDE HAD FRACTURED AND DISENGAGED. THE BROKEN PIECE WAS NOT RETURNED.

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

  MAUDE report 15322715 ↗
• MalfunctionAug 26, 2022Difficult or Delayed Activation; Detachment of Device or Device Component; Difficult or Delayed Activation; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE WAS DIFFICULT TO ACTIVATE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE TIP OF THE WAVEGUIDE HAD FRACTURED AND DISENGAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15306344 ↗
• MalfunctionAug 26, 2022Difficult or Delayed Activation; Detachment of Device or Device Component; Difficult or Delayed Activation; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE HAD AN ACTIVATION ISSUE WHEREIN IT WAS DIFFICULT TO ACTIVATE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND VISUAL INSPECTION OF THE DISPOSABLE DEVICE REVEALED THAT THE TIP OF THE WAVEGUIDE HAD FRACTURED AND DISENGAGED. THE BROKEN PIECE WAS RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15303230 ↗
• MalfunctionMar 7, 2022Device Damaged Prior to Use; Detachment of Device or Device Component; Device Damaged Prior to Use; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE BROKE. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE TIP OF THE WAVEGUIDE HAD FRACTURED, DISENGAGED BUT WAS RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13677908 ↗
• MalfunctionJan 28, 2022Difficult or Delayed Activation; Detachment of Device or Device Component; Difficult or Delayed Activation; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE WAS DIFFICULT TO ACTIVATE. A NEW DISSECTOR WAS USED WITH THE SAME GENERATOR AND BATTERY AND IT WORKED FINE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13382771 ↗
• MalfunctionDec 30, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BYPASS SURGERY, A SMALL PIECE OF METAL WAS FOUND ON THE MESENTERY. THE SMALL PIECE OF METAL WAS FOUND AND REMOVED WITH A GRASPER. THE DEVICE LOOKED AND WORKED NORMALLY HALF WAY THROUGH THE SURGERY, DURING DISSECTION OF THE OMENTUM FOR BYPASS UNTIL THE COMPLETION OF THE SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13118630 ↗
• MalfunctionSep 13, 2021Difficult or Delayed Activation; Detachment of Device or Device Component; Difficult or Delayed Activation; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE WAS DIFFICULT TO ACTIVATE. IT WAS UNKNOWN IF THE DISSECTOR COME INTO CONTACT WITH ANY METAL INSTRUMENTS. A NEW SIMILAR DEVICE WAS USED AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12460717 ↗
• MalfunctionSep 1, 2021Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE DEVICE WAS NOT ACTIVATED. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE TIP OF THE WAVEGUIDE HAD FRACTURED AND DISENGAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12408505 ↗
• MalfunctionJul 8, 2021Detachment of Device or Device Component; Intermittent Energy Output; Detachment of Device or Device Component; Intermittent Energy Output

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN THE DEVICE WAS OPENED AND ATTACHED TO GENERATOR AND BATTERY PACK, IT WAS A GREEN LAMP, BUT AS SOON AS IT WAS ACTIVATED, IT TURNED INTO A RED LAMP AND THE PRODUCT COULD NOT BE USED. IT WAS ABLE TO BE USED WITHOUT PROBLEMS AFTER REPLACEMENT. THERE WAS NO PATIENT INVOLVED. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE TIP OF THE WAVEGUIDE HAD FRACTURED AND DISENGAGED. THE BROKEN PIECE WAS RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12140008 ↗
• MalfunctionMay 27, 2021Difficult or Delayed Activation; Detachment of Device or Device Component; Difficult or Delayed Activation; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE HAND PIECE WAS DIFFICULT TO ACTIVATE. REPLACED WITH NEW SIMILAR DEVICE AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11898737 ↗
• MalfunctionMay 27, 2021Failure 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 WAS DIFFICULT TO ACTIVATE. THEY REPLACED THE DEVICE AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11893936 ↗
• MalfunctionMay 27, 2021Difficult or Delayed Activation; Detachment of Device or Device Component; Difficult or Delayed Activation; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE WAS DIFFICULT TO ACTIVATE. THE CRACK PROPAGATED UNTIL THE WAVEGUIDE FRACTURED. ANOTHER DEVICE WAS USED AND WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11893904 ↗
• MalfunctionMay 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A VATS LOBECTOMY PROCEDURE, THE WHITE PIECE ON THE MOVING JAW DISLODGED. IT WAS STILL INTACT ON INSTRUMENT, BUT PROTRUDING OUT FROM THE JAW. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11777722 ↗
• MalfunctionApr 30, 2021Failure 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 WAS ABLE TO BE USED NORMALLY UNTIL THE MIDDLE OF THE PROCEDURE, BUT IN THE LATTER HALF OF THE PROCEDURE, WHEN THE ACTIVATION BUTTON WAS PRESSED, THE RED INDICATOR ILLUMINATED AND THERE WAS NO ACTIVATION. THE GREEN INDICATOR ILLUMINATED WHILE THE ACTIVATION BUTTON WAS NOT PRESSED. ANOTHER BATTERY INSTALLED ONTO THE HANDPIECE. THEY USED THE SAME DISSECTOR AND EXCHANGED THE GENERATOR, BUT THE SITUATION DID NOT IMPROVE, SO IT WAS JUDGED THAT IT WAS DISSECTOR ISSUE. THEY EXCHANGED THE BATTERY AS WELL, BUT THE SITUATION DIDN'T IMPROVE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT FOUND THAT THE DEVICE'S WAVEGUIDE TIP WAS DISENGAGED AND FRACTURED. THE BROKEN PIECE WAS RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11757537 ↗
• MalfunctionApr 13, 2021Difficult or Delayed Activation; Detachment of Device or Device Component; Difficult or Delayed Activation; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE WAS DIFFICULT TO ACTIVATE. A PART OF THE DEVICE GOT DETACHED BUT IT DID NOT FALL INTO THE PATIENT'S CAVITY. THEY USED A NEW DISSECTOR WITH THE SAME BATTERY AND GENERATOR AND IT WORKED SUCCESSFULLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11657302 ↗