Sonicision 7 SCD7A48Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10884521794801), received between Sep 8, 2022 and Mar 31, 2026 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Tear, Rip or Hole in Device Packaging; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO USE, THE DISSECTOR HAD PACKAGING ISSUE. IT WAS APPEARING DAMAGED OR TORN. THE DEVICE DID NOT BREAK DURING PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE DISSECTOR HAD A FRACTURED WAVEGUIDE. THE DEVICE SHOWED EVIDENCE OF USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24739878 ↗
• MalfunctionNov 24, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT, DURING PROCEDURE, THE DISSECTOR'S TRIGGER WAS STUCK AND THE PERSONNEL HAD TO OPEN A NEW DISSECTOR IN ORDER TO FINISHED THE SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630535 ↗
• MalfunctionNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PROCEDURE, THE PROVIDER REQUESTED A NEW DISSECTOR DUE TO CONTINUOUS BLEEDING WHEN USING. MEDICAL OR SURGICAL INTERVENTION WAS NOT NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23521151 ↗
• MalfunctionNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING PROCEDURE, THE SURGEON SAID THE DEVICE WAS BLEEDING. MEDICAL OR SURGICAL INTERVENTION WAS NOT NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. BLOOD TRANSFUSION WAS NOT NECESSARY. ANOTHER DISSECTOR AND GENERATOR WAS USED WITH THE SAME BATTERY AND IT WORKED FINE. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23511347 ↗
• MalfunctionJun 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A PROCEDURE, THE DISSECTOR TISSUE PAD HAS PEELED OFF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22282133 ↗
• MalfunctionFeb 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING THE THE REPORTER, DURING THE PROCEDURE, A PIECE OF THE PLASTIC ON THE CURVED JAW (ONE OF THE TEETH), BROKE OFF INTO THE PATIENT WHEN ACTIVATING ENERGY. THE SURGEON WAS ABLE TO REMOVE THE SMALL PIECES OF PLASTIC FROM PATIENT, BUT UNABLE TO SEE IF ANY TEETH WERE MISSING FROM THE CURVED JAW. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21313884 ↗
• InjuryFeb 4, 2025Energy Output Problem; Adverse Event Without Identified Device or Use Problem; Energy Output Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST BARIATRIC SLEEVE GASTRECTOMY, A PATIENT EXPERIENCED COMPLICATIONS INVOLVING THE DISSECTOR. THE PATIENT WAS TAKEN BACK TO SURGERY DUE TO BLEEDING, WITH THE ABDOMEN FOUND TO BE FULL OF BLOOD. BLOOD LOSS WAS ESTIMATED BETWEEN 250CCS AND 500CCS, BUT NO TRANSFUSION WAS REQUIRED. A RE-OPERATION OR ADDITIONAL SURGICAL PROCEDURES WERE NECESSARY, AND THE PATIENT WAS BROUGHT BACK TO THE HOSPITAL FOR THE SECOND SURGERY. THE BLEEDING WAS SUSPECTED TO ORIGINATE FROM A DISSECTION AREA, ALTHOUGH THE STAPLE LINE WAS INTACT. THERE WAS A POSSIBLE SEAL FAILURE AROUND A DISSECTION POINT DURING THE PROCEDURE. A DRAIN WAS INSERTED TO MANAGE THE SITUATION. THE EVENT RESULTED IN AN EXTENDED HOSPITALIZATION, WITH THE PATIENT STILL IN THE HOSPITAL. THE BLEEDING EVENTUALLY STOPPED AT THE TIME OF CLOSURE, AND THE PATIENT REMAINED ALIVE. THE BATTERY AND GENERATOR WORKED AS EXPECTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21304700 ↗
• MalfunctionJan 24, 2025Failure to Fire; Adverse Event Without Identified Device or Use Problem; Failure to Fire; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DOCTOR WANTED THE ENTIRE LOT OF THE DISSECTORS BE TESTED DUE TO BLEEDING AND RED LIGHT ISSUES WITH SAME LOT NUMBER PREVIOUSLY USED. THE DOCTOR WOULD LIKE THESE FIVE UNITS TESTED AS HE HAS HAD PREVIOUS ISSUES WITH THE SAME LOT NUMBER. THE DEVICE STOPPED IN LESS THAN FIVE MINUTES. NO PART OF THE DISSECTOR BREAK.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21229756 ↗
• MalfunctionJan 21, 2025Failure to Fire; Adverse Event Without Identified Device or Use Problem; Failure to Fire; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, LESS THAN 3 MINUTES IN LAP SLEEVE GASTRECTOMY, THE DEVICE RANDOMLY GAVE ERRORS WHILE DISSECTING. THERE WAS A BLEEDING OCCURRED. SURGEON WOULD PROCEED AND CAME BACK AND THERE WOULD BE OOZING FROM THE AREA OF PRIOR DISSECTION. NO BLOOD TRANSFUSION NOR MEDICAL INTERVENTION REQUIRED. NO PART OF THE DISSECTOR BROKE. NEW DISSECTOR WAS PLACED ON SAME GENERATOR AND WORKED FINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21197273 ↗
• MalfunctionJan 21, 2025Failure to Fire; Adverse Event Without Identified Device or Use Problem; Failure to Fire; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY, THE DEVICE CONSISTENTLY GAVE ALARMS AND ERROR TONES DESPITE NO METAL OBJECTS BEING NEAR THE JAWS. ADDITIONALLY, BLEEDING OCCURRED DURING THE PROCEDURE. THE DISSECTOR WAS REPLACED, AND NO FURTHER ISSUES WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21197128 ↗
• MalfunctionJan 10, 2025Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem; Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC GASTRIC SLEEVE PROCEDURE, WHILE GOING UP THE GREATER CURVE, THE DISSECTOR WAS NOT SEALING VESSELS. THE PATIENT HAD A BLEEDING. THEY OPENED A NEW DEVICE, AND IT WORKED FINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21124675 ↗
• MalfunctionSep 18, 2024

  SONICISION 7 HANDPIECE WOULD NOT CLOSE/LOCK BATTERY IN PLACE. DEFECTIVE DEVICE IDENTIFIED AND REMOVED FROM SERVICE PRIOR TO PATIENT ENTERING OR (OPERATING ROOM).

  Patient problems: Insufficient Information

  MAUDE report 20245019 ↗
• MalfunctionJun 3, 2024Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING USE, THE HANDPIECE WAS WORKING AT BEGINNING OF CASE BUT THEN STARTED FLASHING RED AND BLUE. A NEW BATTERY WAS TRIED, FOLLOWED BY ANOTHER GENERATOR BUT ALARM CONTINUED. CHANGED THE HANDPIECE AND ISSUE WAS RESOLVED. THERE WAS NO PART OF THE DISSECTOR BROKE AND NO PIECE FELL INSIDE THE PATIENT CAVITY. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE DISPOSABLE DEVICE REVEALED THAT THE DISSECTOR HAD A FRACTURED WAVEGUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19448608 ↗
• MalfunctionJan 26, 2024Entrapment of Device; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Entrapment of Device; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, THE SURGEON WAS USING THE DEVICE TO DISSECT DURING A GASTRIC BYPASS PROCEDURE. THE PRONGS ON THE JAW HINGE MECHANISM OF THE DEVICE PROTRUDE FROM THE SHAFT, AND THE SURGEON INADVERTENTLY TORE OPEN A SMALL VESSEL BY SCRAPING A VESSEL ON THE PRONGS. THE SURGEON WAS ABLE TO USE THE DEVICE TO CONTROL THE BLEEDING, BUT COMPLAINED ABOUT THE DEVICE'S DESIGN AND POINTED OUT THE SHARPNESS OF THE PRONGS AND THE PROBABILITY OF CAUSING INADVERTENT INJURY. ALL PARTS OF THE DEVICE WORKED AS INTENDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 18589397 ↗
• MalfunctionMay 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING MOBILIZATION OF THE STOMACH, THE DEVICE LOOKED LIKE IT HAD FOREIGN OBJECT COMING OUT OF THE JAWS. IT LOOKED LIKE METAL ON THE CAMERA BUT WHEN BROUGHT OUT OF THE BODY, THERE WAS NOT METAL IN THE JAWS. INTENDED TO OPEN A NEW DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16888698 ↗
• MalfunctionFeb 23, 2023Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING PROCEDURE, A BLUE PIECE OF DEBRIS CAME OFF THE WHITE PAD OF THE DEVICE. IT¿S UNKNOWN WHERE IT CAME FROM AND WE COULDN¿T RECREATE PRODUCTION OF THE BLUE PIECE. THE SURGEON WAS SUCCESSFULLY USING THE DISSECTOR ON THE PATIENTS MESENTERY WITH APPROXIMATELY FOUR ACTIVATIONS. THE DEVICE WAS REMOVED FROM THE TROCAR AND RETURNED TO THE BACK TABLE. THE DEVICE WAS REINTRODUCED THROUGH THE TROCAR, JAWS OPENED, AND IT WAS APPLIED TO THE PROXIMAL PORTION OF THE DESCENDING ROUX LIMB TO CREATE AN ENTEROTOMY. THE DEVICE WAS ACTIVATED AND A BLUE PIECE OF DEBRIS THAT APPEARS TO BE NYLON IN MAKEUP ABOUT THE SAME SIZE OF THE WHITE PAD APPEARED ON THE PATIENT¿S JEJUNUM. IT WAS REMOVED AND SET ASIDE AND WILL BE RETURNED WITH THE DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16429900 ↗
• InjurySep 8, 2022Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem; Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, SEAL BURST AFTER ACTIVATION ON TISSUE WHICH LEAD TO POOR HEMOSTASIS AND SURGEON HAD TO USE A BIPOLAR DEVICE TO STOP IMMEDIATE BLEEDING. THEN SURGEON USED HARMONIC FOR THE REMAINDER OF THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15380534 ↗