Sonicision 7 SCD7A26Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884521794788), received between Oct 6, 2022 and Dec 9, 2025 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (10 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2025Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn

  ACCORDING TO THE REPORTER, DURING USE, THE JAWS OF THE THREE DISSECTORS MELTED/DISFIGURED. NO PIECE FROM THE JAW LINER MELTED OFF INTO THE PATIENT'S CAVITY. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE JAW LINER DEGRADED, AND PIECES OF THE JAW LINER WERE MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23757885 ↗
• MalfunctionDec 9, 2025Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn

  ACCORDING TO THE REPORTER, DURING USE, THE JAWS OF THE THREE DISSECTORS MELTED/DISFIGURED. NO PIECE FROM THE JAW LINER MELTED OFF INTO THE PATIENT'S CAVITY. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE JAW LINER DEGRADED, AND PIECES OF THE JAW LINER WERE MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23757703 ↗
• MalfunctionDec 9, 2025Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn

  ACCORDING TO THE REPORTER, DURING USE, THE JAWS OF THE THREE DISSECTORS MELTED/DISFIGURED. NO PIECE FROM THE JAW LINER MELTED OFF INTO THE PATIENT'S CAVITY. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE JAW LINER DEGRADED, AND PIECES OF THE JAW LINER WERE MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23757663 ↗
• MalfunctionApr 30, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN APPENDECTOMY PROCEDURE, THE DEVICE WAS ACTIVATED FOR USE IN ADHESION DETACHMENT, THE TISSUE PAD AT THE TIP WAS BROKEN. IT WAS CONFIRMED THAT THE TISSUE PAD WAS NOT COMPLETELY PEELED OFF. IT WAS ALSO OBSERVED THAT A POWDER-LIKE WHITE SUBSTANCE THAT EJECTS AFTER THE ACTIVATION OF THE DEVICE, BUT IT WAS UNKNOWN WHETHER THE WHITE POWDER EMITTED TO THE TIP OF THE JAW HAD DISSIPATED IN THE ABDOMINAL CAVITY. ADDITIONALLY, HEAT INJURY HAD OCCURRED IN THE PART OF THE INTESTINAL TRACT AT THE ROOT OF THE SHAFT REGION ON THE TISSUE PAD SIDE.

  Patient problems: Bowel Burn; Burn(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 21932137 ↗
• InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A RIGHT LOBE LIVER RESECTION AND CHOLECYSTECTOMY, THE PATIENT'S VENA CAVA WAS INJURED, CAUSING MAJOR BLOOD LOSS. THE PROCEDURE INVOLVED THE USE OF THE SONICISION 7 DEVICE. THE SURGEON STARTED TRANSECTION WITH A BOVIE, GOING ~1CM DEEP. THEN USED THE SONICISION 7 TO TRANSECTION ~2-3CM DEEPER, AND FINISHED THE TRANSECTION WITH THE EGIAUSTND + 11 SIG30AVM RELOADS. THE SPECIMEN WAS REMOVED AND SENT TO PATHOLOGY TO ASSESS MARGINS. LAPS WERE PLACED AGAINST THE RESECTED LIVER AND COMPRESSION WAS HELD FOR 10 MINUTES. THE LAPS WERE REMOVED TO ASSESS THE LIVER, AND THIS IS WHEN THE SURGEON REALIZED THE HOLE IN THE VENA CAVA. THE ESTIMATED BLOOD LOSS WAS APPROXIMATELY 1.5 LITERS. EFFORTS TO CONTROL HEMORRHAGE WERE INITIATED AND CODE BLUE WAS ACTIVATED. A VASCULAR SURGEON WAS CONSULTED INTRAOPERATIVELY AND SUCCESSFULLY REPAIRED THE VENA CAVA DEFECT WITH SUTURES, ACHIEVING HEMOSTASIS. THE SURGICAL SITE WAS LEFT TEMPORARILY OPEN, AND A WOUND VACUUM-ASSISTED CLOSURE (VAC) DEVICE WAS APPLIED, WITH DEFINITIVE CLOSURE COMPLETED LATER. THE WAS PATIENT WAS STABILIZED IN THE ICU POSTOPERATIVELY AND SUBSEQUENTLY DISCHARGED IN STABLE CONDITION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 21902737 ↗
• MalfunctionJan 28, 2025Smoking; Detachment of Device or Device Component; Smoking; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING SURGERY A SMOKE CAME OUT OF THE TIP OF THE DISSECTOR AND THE COATING CAME OFF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21252090 ↗
• MalfunctionNov 19, 2024Failure 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 AND DID NOT COME INTO CONTACT WITH ANY METAL INSTRUMENTS. THERE WAS NO BROKEN PART NOTED. A NEW 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 FOUND THE DISPOSABLE DEVICE REVEALED THAT THE DISSECTOR HAD A FRACTURED WAVEGUIDE. THE TIP WAS RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20730296 ↗
• MalfunctionMay 22, 2024Device Difficult to Setup or Prepare; Self-Activation or Keying; Device Difficult to Setup or Prepare; Self-Activation or Keying

  ACCORDING TO THE REPORTER, DURING TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH), THE DEVICE¿S OUTPUT CONTINUED EVEN THOUGH THE OUTPUT BUTTON WAS NOT PRESSED. WHEN THE OUTPUT BUTTON WAS PRESSED, IT STOPPED. IT WAS USED AFTERWARDS, BUT SAME MANNER EVEN THOUGH THE OUTPUT BUTTON WAS NOT PRESSED, IT CONTINUED TO OUTPUT. WHEN THE OUTPUT BUTTON WAS PRESSED, THE RED LIGHT LIT UP. RE-SETUP WAS ATTEMPTED, BUT THE GENERATOR RUN IDLE FROM THE DEVICE AND COULD NOT BE REMOVED. A NEW SET WAS TAKEN OUT AND DEALT WITH IT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19371773 ↗
• 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 WHIPPLE PROCEDURE, THE DEVICE STOPPED WORKING DUE TO PARTICLES INSIDE THE JOINT OF THE JAW. IT WORKED FOR ABOUT 4 HOURS BEFORE IT STOPPED. IT WAS UNKNOWN IF THE PLASTIC PART IN THE JAWS MELTED. IT WAS ALSO UNKNOWN IF ANY PART OF THE DEVICE COMPLETELY DETACHED OR IF ANY PIECE FELL INTO THE PATIENT¿S CAVITY. X-RAY WAS NOT NEEDED TO LOCATE THE PIECE IN ORDER TO RETRIEVE IT, AND THERE WAS NO ANY ADDITIONAL MEDICAL PROCEDURE NEEDED TO REMOVE THE PIECE FROM THE PATIENT. THERE WERE PIECES FOUND LODGED INSIDE THE JAW THAT WERE DARK AND ALMOST PLASTIC LIKE. THE CASE WAS VERY BLOODY. ADVISED THE NURSE TO CLEAN THE JAWS IN WATER BUT THE NURSE KEPT USING RAYTEC TO WIPE THE JAW AND THE RAYTEC GOT CAUGHT ON THE OUTSIDE OF THE JAWS. ONCE DISLODGING THE PIECES FROM THE JAW, THE ERROR RED LIGHT CAME ON AND IT SMOKED WHEN ACTIVATED. REPLACED THE DEVICE AND USED THE SAME GENERATOR AND SAME BATTERY AND THE NEXT DEVICE WORKED FINE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 19046461 ↗
• MalfunctionDec 18, 2023Smoking; Detachment of Device or Device Component; Smoking; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING VATS PROCEDURE, AT THE BEGINNING, THE PLASTIC HAD BURNED AND FELL OUT FROM JAW AFTER FIRST ACTIVATION OF THE DEVICE ON PATIENT, AND LOTS OF SMOKE CAME OUT. NO PIECE FELL INTO PATIENT'S CAVITY, THE PLASTIC FROM THE JAW FELL WHILE CLEANING, NO X-RAY WAS PERFORMED, NO ADDITIONAL MEDICAL PROCEDURE NEEDED, THE DISSECTOR DID NOT COME INTO CONTACT WITH ANY METALLIC INSTRUMENT OR OBJECT, NO RED LIGHT WAS OBSERVED, AND THE DEVICE WAS WORKING INTERMITTENTLY PRIOR TO THE DISENGAGEMENT OF THE PIECE. A NEW HANDPIECE WAS USED AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18347404 ↗
• MalfunctionDec 15, 2022Arcing; Arcing

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE SPARKED AND THE WHITE PLASTIC WAS LEFT ON THE THYROID TISSUE. THE SURGEON WAS UNSURE IF METAL WAS INVOLVED, BUT FELT LIKE THERE WAS NOT METAL IN THE JAWS. THE DEVICE WAS CHANGED TO ANOTHER DEVICE. THE SURGEON CONFIRMED NO METAL WAS IN THE JAWS, DEVICE SPARKED AGAIN AND WHITE PLASTIC RESIDUE WAS LEFT ON THYROID TISSUE. THE SURGEON CHOSE TO MOVE TO HARMONIC DEVICE TO COMPLETE SURGERY. THE SURGEON REMOVED WHITE PLASTIC REMNANTS AND STOPPED USING DEVICE IMMEDIATELY. ALL ITEMS WERE CHANGED (DISPOSABLE HAND PIECE, BATTERY AND GENERATOR) AND THE DEVICE STILL MALFUNCTIONED. THE SURGEON REFUSED TO CONTINUE TO USE THE DEVICE. THE DEVICE WAS EASILY REMOVED WITH A GRASPER. NO RED LIGHT OBSERVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15988371 ↗
• MalfunctionDec 15, 2022Arcing; Detachment of Device or Device Component; Arcing; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE SPARKED AND THE WHITE PLASTIC WAS LEFT ON THE THYROID TISSUE. THE SURGEON WAS UNSURE IF METAL WAS INVOLVED, BUT FELT LIKE THERE WAS NOT METAL IN THE JAWS. THE DEVICE WAS CHANGED TO ANOTHER DEVICE. THE SURGEON CONFIRMED NO METAL WAS IN THE JAWS, DEVICE SPARKED AGAIN AND WHITE PLASTIC RESIDUE WAS LEFT ON THYROID TISSUE. THE SURGEON CHOSE TO MOVE TO HARMONIC DEVICE TO COMPLETE SURGERY. THE SURGEON REMOVED WHITE PLASTIC REMNANTS AND STOPPED USING DEVICE IMMEDIATELY. ALL ITEMS WERE CHANGED (DISPOSABLE HAND PIECE, BATTERY AND GENERATOR) AND THE DEVICE STILL MALFUNCTIONED. THE SURGEON REFUSED TO CONTINUE TO USE THE DEVICE. THE DEVICE WAS EASILY REMOVED WITH A GRASPER. NO RED LIGHT OBSERVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15988258 ↗
• MalfunctionOct 6, 2022Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE SURGEON WAS USING A DEVICE ON LIVER. IT WAS A BLOODY CASE, JAWS ACCUMULATED A GREAT DEAL OF CHAR. WHITE PORTION OF ACTIVE BLADE APPEARS TO BE COMING OFF. THE SURGEON WAS ACTIVATING IN MAXIMUM MODE TO GET IN TO THE LIVER PARENCHYMA AND THERE WAS A GREAT DEAL OF CHAR. THE SCRUB TECH FELT THAT THE WHITE PIECE ON THE INACTIVE BLADE 'MELTED'. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15555431 ↗