Sonicision SCD396 (UDI 10884521807877)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521807877), received between Aug 13, 2020 and Aug 31, 2021 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 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, A FORCEPS WAS OPENED, THE GENERATOR AND THE BATTERY WERE PLACED (IN THAT ORDER) WHEN THE INSTRUCTOR PRESSED THE BLUE TEST BUTTON, THE GENERATOR SHOWED A RED LIGHT. THEY PRESSED THE BUTTON AGAIN AND GAVE THE GREEN LIGHT. THE CLAMP WORKED FOR ABOUT TWO MINUTES, WHERE THE RED LIGHT APPEARED AGAIN. THE BATTERY AND GENERATOR WERE REMOVED AND THE JAW WAS CLEANED, WHICH OPERATED FOR A SHORT TIME AND AGAIN FAILED (TURNING ON THE RED LIGHT ON THE GENERA-TOR). THE KIT (GENERATOR AND BATTERY) WAS CHANGED, BUT EVEN WITH THE REPLACEMENT, IT CONTINUED TO SHOW A RED LIGHT. THE SURGERY WAS STOPPED DUE TO FORCEPS. AN ULTRASONIC CLAMP WAS OPENED AND THE GENERATOR AND BATTERY WERE PLACED, THE CLAMP AGAIN FAILED (TURNING ON THE RED LIGHT OF THE GENERATOR), THE BATTERY AND GENERATOR WERE REPLACED. IT WAS TESTED TO PLACE THE BATTERY IN THE GENERATOR OF THE OTHER KIT, BUT THE CLAMP STILL FAILED (RED LIGHT). 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. IT WAS VERIFIED THAT NOTHING FELL INTO THE PATIENT'S CAVITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12393539 ↗
• MalfunctionJul 27, 2021Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE CUTTER TIP BROKE AND DETACHED FROM THE SCABBARD. THE EQUIPMENT SECTION IMMEDIATELY INVESTIGATED THE INCIDENT. IT WAS UNDERSTOOD THAT DURING THE OPERATION OF THE PATIENT, THE INTRAOPERATIVE DEVICE ALARMED AND COULD NOT CONTINUE TO WORK. THE DOCTOR TOOK OUT THE WIRELESS ULTRASONIC HEMOSTATIC DISSECTOR AND CLEANED AND WIPED IT. DURING THE INSPECTION, THE GRASPING TOOTH OF THE CUTTER TIP BROKE AND FELL OFF, SO IMMEDIATELY STOPPED USING IT. NOTHING FELL ON PATIENT'S CAVITY. IT WAS REPLACED WITH SIMILAR DEVICE AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12231606 ↗
• MalfunctionMar 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE'S JAW BROKE DURING USE ON PATIENT. THE REPORTER CONFIRMED THAT IT BROKE OFF AND FELL INTO PATIENT'S CAVITY BUT IT WAS RETRIEVED AND NO X-RAY WAS NEEDED. A NEW DEVICE WAS USED AND WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11517429 ↗
• MalfunctionMar 16, 2021Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTROPLASTY, THE DISSECTOR STOPPED WORKING AFTER 1 HOUR AND 20 MINUTES OF BEING USE. ERROR TONES WERE HEARD AND RED LIGHTS WERE OBSERVED. ISSUE WAS ISOLATED BY PERFORMING TESTS WITH ANOTHER GENERATOR AND ANOTHER BATTERY, WITHOUT SUCCESS. ANOTHER SIMILAR DEVICE 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 NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11494917 ↗
• MalfunctionFeb 25, 2021Break; Material Separation; Detachment of Device or Device Component; Break; Material Separation; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A HYSTERECTOMY PROCEDURE, THE DEVICE¿S CLAMP BROKE DURING CLEANING AND WHILE IN USE. NOTHING BROKE OFF. THEY REPLACED THE DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION AVAILABLE. MEDTRONIC INVESTIGATION 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 11377990 ↗
• MalfunctionFeb 25, 2021Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PERITONEAL ENDOMETRIOSIS, THE DEVICE'S RED LIGHT ACTIVATED AFTER 20 MINUTES IN THE SURGERY. THE BATTERY AND GENERATOR WAS CHANGED BUT CHANGING THE DEVICE WAS NECESSARY TO FINISH THE PROCEDURE. BASED ON THE INVESTIGATION, THE CRACK PROPAGATED UNTIL THE WAVEGUIDE FRACTURED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11377841 ↗
• MalfunctionJan 29, 2021Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN THE 40 MINUTES OF PROCEDURE, THE DEVICE STOPPED WORKING AND WAS EXCHANGED FOR ANOTHER. NO PARTS FELL INTO THE PATIENT CAVITY AND THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE TIP OF THE WAVE GUIDE HAD FRACTURED AND DISENGAGED. THE BROKEN PIECE WAS NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11251236 ↗
• MalfunctionDec 11, 2020Failure 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. THERE WAS AN ERROR TONES HEARD OR RED LIGHTS OBSERVED. THEY CHANGED THE BATTERY AND GENERATOR BUT STILL DID NOT WORK. DEVICE WAS BROKEN AND FULLY DISENGAGED BUT DID NOT FALL INTO PATIENT CAVITY. THEY REPLACED ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10992209 ↗
• MalfunctionAug 13, 2020Break; Failure to Fire; Detachment of Device or Device Component; Break; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE FOR ENDOMETRIOSIS, THE DISSECTOR STOPPED WORKING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT FOUND THAT THE DEVICE'S WAVEGUIDE TIP WAS BROKEN OFF AND FRACTURED. THE BROKEN PIECE WAS NOT RETURNED. UPON FOLLOW UP, THE DISSECTOR BROKE AND NO PARTS FELL INTO PATIENT CAVITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10405564 ↗