Sonicision SCD26Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 10884521195219), received between May 9, 2016 and Apr 14, 2026 — classified as 2 injuries, 65 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (27 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 25 most recent of 67 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A PROCEDURE, THE JAWS OF THE HANDPIECE DID NOT OPEN. ANOTHER HANDPIECE WAS USED WITH THE SAME GENERATOR AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24872684 ↗
• MalfunctionMar 18, 2026Failure to Cut; Difficult to Open or Close; Intermittent Energy Output

  IT WAS REPORTED DURING THE LAPAROSCOPIC COLECTOMY, THE PHYSICIAN CLOSED THE DEVICE, SEALED, THEN WENT TO CUT AND RELEASE, BUT IT WOULD NOT CUT AND RELEASE FROM ILEOCOLIC VASCULAR PEDICLE AFTER 20 MINUTES OF THE PROCEDURE. THE DEVICE'S KNIFE BLADE WAS EXTENDED. THE DEVICE WAS RELEASED FROM THE TISSUE BY FORCEFULLY PULLING THE HANDLES APART. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24629100 ↗
• MalfunctionFeb 24, 2026Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING SURGERY, THE DEVICE SHOWED AN INCOMPLETE SEAL CYCLE ERROR CODE 404 SEAL OPEN CIRCUIT EVEN WHEN HOLDING THE TWO JAWS AND THE BOTTOM OF SEALING AND THERE WAS NO ENERGY AT ALL. THE SURGICAL TIME WAS EXTENDED TO 1 HOUR. ANOTHER LIGASURE HANDPIECE WAS USED WITH THE SAME GENERATOR AND IT WORKED FINE. PHOTO OBSERVATION SHOWED ALSO ERROR CODES 235 AND 326.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24431702 ↗
• MalfunctionFeb 15, 2026Difficult to Open or Close; Intermittent Energy Output

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOWER ANTERIOR RESECTION, THE HANDPIECE WAS NOT OPENING AND CLOSING PROPERLY AFTER 30MINUTES OF USE. IT WAS NOT ABLE TO LATCH WHEN APPLIED TO MESENTERY TISSUE. IT WAS CLEANED ONCE AND THE KNIFE BLADE WAS NOT EXTENDED NOR PROTRUDED BEYOND THE EDGE OF THE JAWS. ANOTHER HANDPIECE WAS USED WITH THE SAME GENERATOR AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24341674 ↗
• MalfunctionFeb 11, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY INVOLVING DISSECTION OF THE BROAD LIGAMENT, THE DEVICE WAS DIFFICULT OR IMPOSSIBLE TO OPEN, BECAME STUCK ON TISSUE, AND THE JAWS WERE FORCED OPEN TO REMOVE THE DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24319583 ↗
• MalfunctionFeb 3, 2026Energy Output Problem; Intermittent Energy Output

  IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY THE LIGASURE BLUNT TIP SEALER DIVIDER DID NOT COAGULATE SHORT VESSELS DESPITE A COMPLETE FUSION CYCLE, RESULTING IN INADEQUATE OR PARTIAL SEALING WITH EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD. THERE WAS NO RE-GRASP ALERT. THE PROCEDURE WAS EXTENDED BY 5-10 MINUTES. THE TISSUE BEING SEALED WAS A SHORT VESSEL WITH AN APPROXIMATE THICKNESS OF 7 MM, AND THE JAWS WERE CLEAN AS IT WAS THE BEGINNING OF THE PROCEDURE. BETWEEN 5-10 GOOD SEALS OCCURRED BEFORE THE ISSUE. ANOTHER DEVICE WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 24245104 ↗
• MalfunctionFeb 3, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE BLUNT TIP SEALER DIVIDER LF1837 WAS APPLIED TO TISSUE AND WOULD NOT UNGRASP AFTER FIRING. THE DEVICE REQUIRED A REPEAT CAUTERY/CUT SEQUENCE TO RELEASE THE TISSUE. A SECOND LIGASURE DEVICE WAS USED TO FINISH THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24244463 ↗
• MalfunctionJan 8, 2026Device Alarm System; Energy Output Problem

  IT WAS REPORTED THAT AN INCOMPLETE SEAL MESSAGE OCCURRED MID LAPAROSCOPIC HYSTERECTOMY DESPITE TROUBLESHOOTING. CLEANED THE TIPS OF THE DEVICE, ENSURED THERE WAS AN APPROPRIATE AMOUNT OF TISSUE BEING GRASPED SURGICALLY. UNPLUGGED AND RE-PLUGGED BUT KEPT REPEATING INCOMPLETE SEAL. A SECOND DEVICE WAS OPENED AND USED WITH THE SAME GENERATOR AND IT DID WORK FINE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24006109 ↗
• MalfunctionJan 8, 2026Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, AFTER CAUTERIZING, THE DEVICE DID NOT UNLOCK. IT TOOK THE SURGEON APPROXIMATELY FIVE MINUTES TO UNLOCK THE DEVICE. THIS RESULTED IN ADDITIONAL TIME UNDER ANESTHESIA, A DELAY IN TREATMENT/THERAPY, AND UNEXPECTED OR PROLONGED CARE.

  Patient problems: Insufficient Information

  MAUDE report 24003326 ↗
• MalfunctionDec 26, 2025Retraction Problem; Difficult to Open or Close; Retraction Problem; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION FOR MOBILIZATION OF THE COLON, THE BLUNT TIP SEALER DIVIDER LF1837 WAS PLUGGED INTO AN FT10 GENERATOR AND EXPERIENCED MULTIPLE ISSUES, INCLUDING THE HANDLE BEING STUCK IN THE PULLED POSITION AND THE JAWS BECOMING STUCK IN THE CLOSED POSITION AFTER USE. A NEW LIGASURE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE SURGICAL TIME WAS EXTENDED BY 5 MINUTES DUE TO THESE PRODUCT ISSUES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23894895 ↗
• MalfunctionDec 17, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE USING THE LIGASURE VESSEL SEALING DEVICE, THE JAWS WOULD NOT OPEN, MAKING THE DEVICE DIFFICULT OR IMPOSSIBLE TO OPEN AND CAUSING IT TO BECOME STUCK ON TISSUE. THE PROCEDURE WAS EXTENDED BY 15 MINUTES AS A RESULT. THE DEVICE WAS PLUGGED INTO AN FT10 GENERATOR, AND ANOTHER LIGASURE DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR. THE DEVICE WAS REMOVED BY RESECTING THE SURROUNDING TISSUE USING SCISSORS ON THE SIDE OF THE JAW, AFTER WHICH THE JAWS EVENTUALLY PARTED.

  Patient problems: Tissue Breakdown

  MAUDE report 23827846 ↗
• MalfunctionDec 17, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT, DURING A LAPAROSCOPIC HEMICOLECTOMY, THE HANDPIECE JAWS DID NOT SEAL COMPLETELY UPON FIRING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23826051 ↗
• MalfunctionNov 11, 2025Energy Output Problem; Intermittent Energy Output; Energy Output Problem; Intermittent Energy Output

  IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, THE DEVICE HAD INADEQUATE OR PARTIAL SEALING WITH EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD. THERE WERE 5-10 GOOD SEALS WERE COMPLETED BEFORE THE PROBLEM OCCURRED. ANOTHER LIGASURE DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23521276 ↗
• MalfunctionNov 10, 2025Difficult to Open or Close; Intermittent Energy Output; Difficult to Open or Close; Intermittent Energy Output

  IT WAS REPORTED THAT NEAR THE END OF A GYNECOLOGICAL PROCEDURE, THE JAWS OF THE HANDPIECE WERE NOT OPENING OR CLOSING PROPERLY, DESCRIBING THEN AS "STIFF". BY THAT POINT THE VESSEL SEALING PORTION OF THE PROCEDURE WAS FINISHED, SO HE DIDN'T NEED TO OPEN A NEW DEVICE. ANOTHER HANDPIECE WAS WORKING PROPERLY WITH THE SAME GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23512073 ↗
• MalfunctionNov 5, 2025Difficult to Open or Close; Intermittent Energy Output; Difficult to Open or Close; Intermittent Energy Output

  IT WAS REPORTED THAT DURING A LIGASURING THE SUPPORTIVE LIGAMENTS OF THE UTERUS ON TOTAL LAPAROSCOPIC HYSTERECTOMY AND BILATERAL SAL PINGO-OOPHORECTOMY (TLH/BSO), ABOUT 20 MINUTES OF USE, THE DEVICE'S JAW WOULD NOT OPEN AND BECAME STUCK ON TISSUE AFTER ACTIVATING. THE JAWS HAD TO BE PULLED OFF THE TISSUE. IT WAS NOTED THAT DEVICE WAS NOT REPROCESSED OR REFURBISHED. OPEN ANOTHER LIGASURE DEVICE AND USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23474142 ↗
• MalfunctionOct 23, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY AND SALPINGO-OOPHORECTOMY INVOLVING DISSECTION OF TISSUE AROUND THE UTERUS, TWO HANDPIECES WERE REPORTED TO HAVE A JAW ISSUE, MAKING IT DIFFICULT OR IMPOSSIBLE TO OPEN, AND BECAME STUCK ON TISSUE. THE JAWS WERE FORCED OPEN TO REMOVE THE DEVICE, WHICH RESULTED IN AN EXTENDED SURGICAL TIME OF 10 MINUTES. ANOTHER LIGASURE DEVICE WITH A DIFFERENT LOT NUMBER WAS USED SUCCESSFULLY WITH THE SAME GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23367943 ↗
• MalfunctionOct 23, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY AND SALPINGO-OOPHORECTOMY INVOLVING DISSECTION OF TISSUE AROUND THE UTERUS, TWO HANDPIECES WERE REPORTED TO HAVE A JAW ISSUE, MAKING IT DIFFICULT OR IMPOSSIBLE TO OPEN, AND BECAME STUCK ON TISSUE. THE JAWS WERE FORCED OPEN TO REMOVE THE DEVICE, WHICH RESULTED IN AN EXTENDED SURGICAL TIME OF 10 MINUTES. ANOTHER LIGASURE DEVICE WITH A DIFFERENT LOT NUMBER WAS USED SUCCESSFULLY WITH THE SAME GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23367681 ↗
• MalfunctionAug 23, 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, THE DEVICE BROKE (PHYSICALLY DAMAGED) PRIOR TO USE ON PATIENT. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE DISSECTOR HAD A FRACTURED AND DETACHED WAVEGUIDE. THE WAVEGUIDE WAS RETURNED AND NO PIECE OF THE DEVICE WAS MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20049709 ↗
• MalfunctionDec 28, 2023Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE COULD NOT OPEN AND CLOSED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18414236 ↗
• MalfunctionDec 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, A METAL PIECE WAS FOUND IN THE PATIENT'S ABDOMINAL CAVITY IN THE OPERATING ROOM. IT WAS TAKEN OUT IMMEDIATELY. AFTER CHECKING ALL THE INSTRUMENTS, ONLY THE ULTRASONIC SCALPEL MAY HAVE DROPPED THE METAL PIECE. IT WAS REPLACED IMMEDIATELY AND THE OPERATION CONTINUED NORMALLY.

  Patient problems: Insufficient Information

  MAUDE report 18283612 ↗
• MalfunctionMar 22, 2023Detachment of Device or Device Component; Noise, Audible; Detachment of Device or Device Component; Noise, Audible

  ACCORDING TO THE REPORTER, DURING STENOSIS, THE DEVICE UNUSUAL SOUND OR NOISY. NO PART OF THE PRODUCT FELL INTO ANY OF THE PATIENT'S CAVITY. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE DISSECTOR HAD A FRACTURED WAVEGUIDE AND THE TIP WAS NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16591039 ↗
• 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 GASTRECTOMY PROCEDURE, THE DEVICE WAS DIFFICULT TO ACTIVATE. TRIED WITH ANOTHER EQUIPMENT BUT THE CALIPER CONTINUED TO FAIL, THEN ANOTHER CALIPER FROM A DIFFERENT BATCH WAS PASSED AND THAT NEW CALIPER WORKED IN THE TWO EQUIPMENT THAT WAS THERE AND COMPLETED 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15323605 ↗
• MalfunctionJun 30, 2021Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC THYROIDECTOMY, THE TWEEZERS FAILED AFTER 1 HOUR AND 40 MINUTES OF USE, IT SIGNALED WITH AN AUDIBLE AND LIGHT SIGNAL. THE ACTIVE TIP OF THE JAW BROKE. THERE WAS NO CONTACT WITH ANY METALLIC STRUCTURE OR ANYTHING THAT COULD DAMAGE THE CLAMP. TWEEZERS BROKE AT THE ACTIVE TIP, AFTER TRIGGERING THE FABRIC. THE ATTACHED PHOTO OF THE DEVICE SHOWN THAT THE TIP WAS BROKEN OFF AND THE BROKEN PIECE WAS ALSO SEEN IN THE PICTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12096390 ↗
• MalfunctionJun 10, 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 DEVICE DID NOT WORK WHEN THEY CHANGED THE BATTERY AND THE CHARGER. THEY USED ANOTHER DISSECTOR WITH THE SAME GENERATOR AND BATTERY AND IT WORKED FINE. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND. THE TIP OF THE WAVEGUIDE HAD FRACTURED AND DISENGAGED. THE BROKEN PIECE WAS NOT RETURNED. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER STATED THAT THE DEVICE DID NOT BROKE DURING PROCEDURE AND THERE WAS NO ANY OTHER MEDICAL PROCEDURE AND IMAGING DONE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11980098 ↗
• MalfunctionJan 7, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE'S TIP BROKE DURING USE ON A PATIENT. THE BROKEN TIP WAS REMOVED FROM PATIENT CAVITY IMMEDIATELY. ANOTHER SONICISION DISSECTOR DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11132731 ↗