Sonicision 7 SCD7A39Recalls & reported problems

Summary

The FDA's MAUDE database contains 112 adverse event reports that list this exact device (DI 10884521794795), received between Mar 15, 2023 and Sep 21, 2026 — classified as 10 injuries, 102 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (78 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 112 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848982 ↗
• MalfunctionSep 21, 2026Self-Activation or Keying

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848952 ↗
• MalfunctionAug 28, 2026Failure to Fire; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50493618 ↗
• MalfunctionAug 25, 2026Material Separation; Failure to Fire; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50435384 ↗
• MalfunctionJul 31, 2026Failure to Fire; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50099830 ↗
• MalfunctionMay 12, 2026Failure to Deliver Energy; Difficult or Delayed Activation; Failure to Cut; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A LAPAROSCOPIC PARAESOPHAGEAL HERNIA REPAIR, THE DEVICE'S WHITE TEFLON AT THE JAW WAS SLIDING IN AND OUT AND APPEARED TO BE COMING OFF. THE SURGEON MENTIONED THAT IT WAS TAKING MORE TIME THAN USUAL TO CUT AND BURN THE TISSUE. A NEW DEVICE WAS OPENED.

  Patient problems: Insufficient Information

  MAUDE report 25149599 ↗
• MalfunctionApr 21, 2026Failure to Fire; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING PROCEDURE, THE DISSECTOR WOULD NOT ACTIVATE. THE DISSECTOR DID NOT COME INTO CONTACT WITH ANY METAL INS TRUMENTS. A PART OF THE DISSECTOR HAD COMPLETELY DETACHED FROM THE DEVICE BUT IT DID NOT FELL INTO THE PATIENT'S CAVITY. X-RAY WAS NOT NECESSARY AND THERE WAS FULL PRODUCT COUNT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24940489 ↗
• MalfunctionApr 14, 2026Failure to Fire; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PROCEDURE, THE DEVICE WAS USABLE AT FIRST BUT PARTWAY THROUGH IT WAS NO LONGER ABLE TO OUTPUT. THE BATTERY WAS REPLACED BUY THE BATTERY STILL COULD NOT BE USED AND SO THE DEVICE WAS REPLACED WITH A NEW ONE. NO PART OF THE DISSECTOR BROKE. THERE WAS NO PATIENT HARM/INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THE DISSECTOR HAD A FRACTURED WAVEGUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24872953 ↗
• MalfunctionApr 11, 2026Failure to Fire; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PROCEDURE, THE DISSECTOR WOULD NOT ACTIVATE. THE DISSECTOR WAS REPLACED WITH A NEW ONE AND THE SURGERY WENT WELL. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE DISSECTOR WAS BROKEN OFF AND RETURNED. USE AFTER DAMAGE CAN CAUSE THE CRACKED WAVEGUIDE TO BREAK OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24847447 ↗
• MalfunctionApr 3, 2026Failure to Fire; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PROCEDURE, THE SURGERY STARTED WITH THE CLAMP AND IT WORKED WELL, AFTER A WHILE, THE GENERATOR SHOWED A RED LIGHT, IT WAS DISASSEMBLED AND REASSEMBLED AND THE ERROR PERSISTS, THE GENERATOR AND BATTERY WERE CHANGED AND IT CONTINUED TO SHOW RED; THE CLAMP WAS CHANGED AND EVERYTHING WORKED. NO PART OF THE DISSECTOR BROKE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION FOUND THAT THE DEVICE SHOWED EVIDENCE OF USE. DEBRIS WAS NOTED UNDER THE ACTIVATION BUTTON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24777893 ↗
• MalfunctionMar 18, 2026Device Difficult to Setup or Prepare; Failure to Fire; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PROCEDURE, THERE WAS A SLIGHT DISCOMFORT WHEN CONNECTING AND THE DEVICE WAS USED AS IS BUT AFTER ABOUT 2 HOURS RED LIGHT TURNED ON AND IT COULD NOT BE USED. THE BATTERY WAS REPLACED BUT THE ISSUE WAS NOT RESOLVED. THE DISSECTOR AND GENERATOR WAS ATTEMPTED TO BE DETACHED FROM EACH OTHER BUT THEY COULD NOT BE DETACHED. ANOTHER DEVICE WAS TAKEN OUT AND USED. A DISTRIBUTOR'S REPRESENTATIVE USED TOOLS TO DETACH THE DISSECTOR AND GENERATOR. AFTERWARDS THE GENERATOR WAS CONNECTED TO ANOTHER DISSECTOR AND COULD BE USED WITHOUT ISSUES. THE DISSECTOR DID NOT COME INTO CONTACT WITH ANY METAL INSTRUMENT. ANOTHER DISSECTOR WAS USED WITH THE SAME GENERATOR AND BATTERY AND WORKED FINE. THE CONNECTION PART BETWEEN THE DISSECTOR AND GENERATOR BROKE. IT WAS COMPLETELY REMOVED AND DID NOT FALL INTO THE PATIENT'S CAVITY. THERE WAS NO PATIENT HARM/INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24629159 ↗
• MalfunctionMar 16, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING LAPAROSCOPIC MYOMECTOMY, THE FIRST DEVICE'S BLADE SNAPPED OFF INTO THE PATIENT. A SECOND DEVICE WAS OPENED, AND THE CASE CONTINUED, BUT A RED ERROR TONE BEGAN APPROXIMATELY 20 MINUTES INTO ITS USE. THEY PROCEEDED TO OPEN THREE MORE DEVICES, ALL OF WHICH CONTINUED TO EMIT ERROR TONES. THE BROKEN PIECE WAS RETRIEVED AND REMOVED WITHOUT THE USE OF AN X-RAY. THERE WAS NO PATIENT HARM/INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24607819 ↗
• MalfunctionMar 12, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING USE, THE DEVICE'S TIP BROKE OFF.

  Patient problems: Insufficient Information

  MAUDE report 24577720 ↗
• MalfunctionMar 7, 2026Failure to Fire; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING PROCEDURE, THE DISSECTOR WAS ASSEMBLED SUCCESSFULLY WITH A GREEN LIGHT, CONFIRMING GOOD STATUS. UPON INITIAL ACTIVATION THE DISSECTOR HAD SWITCHED OFF COMPLETELY AND WAS NOT INTRODUCED TO THE PATIENT CAVITY. THE DISSECTOR DID NOT BREAK. THE SAME GENERATOR AND BATTERY WERE USED ON THE SECOND DISSECTOR AND THEY WORKED PERFECTLY. THE DISSECTOR DID NOT COME INTO CONTACT WITH ANY METAL INSTRUMENTS. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE DISSECTOR HAD A FRACTURED WAVEGUIDE. THE WAVEGUIDE WAS NOT RETURNED WITH THE DEVICE. THE DEVICE MALFUNCTIONED AFTER ASSEMBLY BEFORE IT WAS INTRODUCED INSIDE THE PATIENTS CAVITY. THE DEVICE WAS NOT INTRODUCED INSIDE THE PATIENTS CAVITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24541194 ↗
• MalfunctionMar 3, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING PROCEDURE, THE ACTIVE BLADE BROKE DURING USE. PHOTO OBSERVATION SHOWED THAT THE ACTIVE BLADE BROKE OFF. THE BROKEN PIECE FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED WITHOUT THE USE OF AN X-RAY OR ADDITIONAL MEDICAL PROCEDURE. THE DISSECTOR DID NOT COME INTO CONTACT WITH ANY METAL INSTRUMENTS. THERE WAS NO PATIENT HARM/INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24499666 ↗
• MalfunctionFeb 4, 2026Failure to Fire; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ROBOT ASSISTED PROCEDURE, THE DISSECTOR HAD ERRORS OCCURRED FREQUENTLY MIDWAY AND WOULD NOT BE OUTPUT. THE DEVICE DID NOT COME IN CONTACT TO ANY METALLIC APPARATUS. ANOTHER DISSECTOR WAS USED WITH THE SAME GENERATOR AND BATTERY AND IT WORKED FINE. THERE WAS NO DAMAGE CONFIRMED VISUALLY. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THE JAW LINER DEGRADED AND WAS DETACHED. THERE WAS NO MISSING PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259450 ↗
• MalfunctionFeb 3, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PROCEDURE, IN THE MIDDLE OF THE CASE WHILE PERFORMING TISSUE DISSECTION THE BLADE DETACHED AND FELL INTO THE CAVITY. UPON DETACHMENT THE DOCTORS SEARCHED FOR FIVE MINUTES FOR THE PIECE THAT HAD BROKEN OFF FROM THE DISSECTOR. THE PIECE THAT BROKE OFF WAS RETRIEVED WITHOUT THE USE OF AN X-RAY OR ADDITIONAL PROCEDURE. THE DEVICE WAS WORKING NORMALLY PRIOR TO DISENGAGEMENT OF THE PIECE. THE DEVICE DID NOT COME INTO CONTACT WITH ANY METAL INSTRUMENTS. PHOTO OBSERVATION SHOWS THAT THE ACTIVE WAVEGUIDE IS MISSING FROM THE DISSECTOR. THERE WAS NO PATIENT HARM/INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245456 ↗
• MalfunctionFeb 3, 2026Failure to Deliver Energy; Failure to Fire; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING LAPAROSCOPIC CHOLECYSTECTOMY, THE DEVICE STOPPED WORKING AND HAD A RED LIGHT. IT ALSO HAD NO COAGULATION ISSUE. THE BATTERY WAS SWITCHED THEN THE ACTIVE BLADE BROKE OFF INTO THE PATIENT WHICH HAD TO BE RETRIEVED. THERE WAS NO PATIENT HARM/INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24244785 ↗
• MalfunctionFeb 3, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PROCEDURE, THE DOCTOR COMMENTED THAT THE DEVICE DOES NOT FUNCTION CORRECTLY AND STICKS TO THE TISSUE. THE SURGICAL ASSISTANT WAS ASKED TO CHECK AND CLEAN THE TIP. UPON CLEANING IT WAS NOTICED THAT THE MOVABLE PART OF THE LOWER JAW WAS LOOSE AND WHEN TRYING TO CLEAN IT, IT DETACHED EASILY. THE DEVICE WAS CHANGED AND THE PROCEDURE CONTINUED WITHOUT ISSUES. THERE WAS NO PATIENT HARM/INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24243899 ↗
• InjuryFeb 2, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC UTERINE MYOMECTOMY, THE FIRST DEVICE USED AT THE BEGINNING OF THE CASE MALFUNCTIONED, DISPLAYING A FLASHING RED LIGHT AND EMITTING AN AUDIBLE ERROR TONE. THE SURGEON THEN REQUESTED THAT A SECOND DEVICE BE OPENED. AFTER ONLY A FEW MINUTES OF USE, WHILE CUTTING THROUGH THE MYOMETRIUM, THE ACTIVE BLADE OF THE SECOND DEVICE SNAPPED OFF AND FELL INTO THE PATIENT. X-RAY AND FLUOROSCOPY WERE USED TO LOCATE THE DETACHED BLADE, WHICH WAS ULTIMATELY FOUND NEAR THE LIVER AND SMALL BOWEL. THIS INCIDENT WAS ESTIMATED TO HAVE ADDED APPROXIMATELY THREE HOURS TO THE PROCEDURE. THE DEVICE HAD FUNCTIONED NORMALLY PRIOR TO THE BLADE DISENGAGEMENT. FOLLOWING RETRIEVAL OF THE BLADE, A THIRD DEVICE WAS OPENED; HOWEVER, IT ALSO PRODUCED A RED ERROR TONE AND STOPPED WORKING. A FOURTH DEVICE WAS THEN OPENED AND WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 24235418 ↗
• InjuryFeb 2, 2026Failure to Fire; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC UTERINE MYOMECTOMY, THE FIRST DEVICE USED AT THE BEGINNING OF THE CASE MALFUNCTIONED, DISPLAYING A FLASHING RED LIGHT AND EMITTING AN AUDIBLE ERROR TONE. THE SURGEON THEN REQUESTED THAT A SECOND DEVICE BE OPENED. AFTER ONLY A FEW MINUTES OF USE, WHILE CUTTING THROUGH THE MYOMETRIUM, THE ACTIVE BLADE OF THE SECOND DEVICE SNAPPED OFF AND FELL INTO THE PATIENT. X-RAY AND FLUOROSCOPY WERE USED TO LOCATE THE DETACHED BLADE, WHICH WAS ULTIMATELY FOUND NEAR THE LIVER AND SMALL BOWEL. THIS INCIDENT WAS ESTIMATED TO HAVE ADDED APPROXIMATELY THREE HOURS TO THE PROCEDURE. THE DEVICE HAD FUNCTIONED NORMALLY PRIOR TO THE BLADE DISENGAGEMENT. FOLLOWING RETRIEVAL OF THE BLADE, A THIRD DEVICE WAS OPENED; HOWEVER, IT ALSO PRODUCED A RED ERROR TONE AND STOPPED WORKING. A FOURTH DEVICE WAS THEN OPENED AND WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 24234492 ↗
• InjuryFeb 2, 2026Failure to Fire; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC UTERINE MYOMECTOMY, THE FIRST DEVICE USED AT THE BEGINNING OF THE CASE MALFUNCTIONED, DISPLAYING A FLASHING RED LIGHT AND EMITTING AN AUDIBLE ERROR TONE. THE SURGEON THEN REQUESTED THAT A SECOND DEVICE BE OPENED. AFTER ONLY A FEW MINUTES OF USE, WHILE CUTTING THROUGH THE MYOMETRIUM, THE ACTIVE BLADE OF THE SECOND DEVICE SNAPPED OFF AND FELL INTO THE PATIENT. X-RAY AND FLUOROSCOPY WERE USED TO LOCATE THE DETACHED BLADE, WHICH WAS ULTIMATELY FOUND NEAR THE LIVER AND SMALL BOWEL. THIS INCIDENT WAS ESTIMATED TO HAVE ADDED APPROXIMATELY THREE HOURS TO THE PROCEDURE. THE DEVICE HAD FUNCTIONED NORMALLY PRIOR TO THE BLADE DISENGAGEMENT. FOLLOWING RETRIEVAL OF THE BLADE, A THIRD DEVICE WAS OPENED; HOWEVER, IT ALSO PRODUCED A RED ERROR TONE AND STOPPED WORKING. A FOURTH DEVICE WAS THEN OPENED AND WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 24234402 ↗
• MalfunctionJan 23, 2026

  DEVICE DEFECT. DOOR TO LOCK BATTERY WOULD NOT LOCK IN PLACE. EVENT OCCURRED WHILE SETTING UP CARE FOR THE PROCEDURE IN THE OR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160628 ↗
• MalfunctionJan 12, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING PROCEDURE, THE DISSECTOR DID NOT WORK. IT WAS REMOVED FROM THE PATIENT'S CAVITY AND IT BROKE OUTSIDE. THE DISSECTOR DID NOT COME INTO CONTACT WITH ANY METAL INSTRUMENTS. THE DEVICE DID NOT BREAK DURING CLEANING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24036822 ↗
• MalfunctionJan 6, 2026Failure to Fire; Detachment of Device or Device Component

  IT WAS REPORTED THAT ONE HOUR AFTER A LAPAROSCOPIC HYSTERECTOMY WITH MYOMECTOMY PROCEDURE STARTED, THE KNIFE TRIGGER BECAME STUCK, CAUSING BOTH THE PULL HANDLE AND KNIFE TRIGGER TO BE UNABLE TO RETURN TO THEIR ORIGINAL POSITIONS. IT WAS APPLIED ON TISSUE WHEN THE ISSUE HAPPENED BUT TISSUE SEPARATE FROM DEVICE AFTER ACTIVATE AND CUT, HENCE NO PROBLEM TO REMOVE FROM TISSUE. KNIFE BLADE DID NOT EXTEND NOR PROTRUDE BEYOND THE EDGE OF JAWS. A SONICISION DISSECTOR WAS USED BUT IT DID NOT ACTIVATE THOUGH IT DID NOT COME INTO CONTACT WITH ANY METAL INSTRUMENTS. TROUBLESHOOTING INCLUDED DISASSEMBLING AND RE-ASSEMBLING THE DISSECTOR, BUT IT REMAINED NONFUNCTIONAL AROUND 30 MINUTES AFTER THE IT STARTED. THE GENERATOR WAS TESTED WITH ANOTHER DISSECTOR AND FUNCTIONED PROPERLY. ANOTHER LIGASURE DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR. 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 BROKEN WAVEGUIDE AND THE BROKEN PIECE WAS NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973141 ↗