Sonicision SCD48Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10884521195226), received between Mar 20, 2017 and May 18, 2022 — classified as 8 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (11 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2022Break; Loose or Intermittent Connection; Failure to Fire; Detachment of Device or Device Component; Break; Loose or Intermittent Connection; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE BROKE DURING USE ON A PATIENT. THE RED LIGHT WAS TURNED ON AND IT WAS OBSERVED THAT THE TIP OF THE CLAMP HAD BROKEN OFF IN THE ABDOMINAL CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14428668 ↗
• MalfunctionNov 2, 2021Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC VERTICAL GASTRECTOMY, THE DISSECTOR STOPPED WORKING PAST 30 MINUTES SINCE THE BEGINNING OF SURGERY. THE DEVICE SHOWED RED LIGHT, BATTERY AND GENERATOR WERE TESTED WITH SECOND DEVICE AND WORKED PERFECTLY. THE SURGERY WAS COMPLETED WITH SECOND DEVICE. THERE WAS NO PATIENT INJURY. PATIENT WAS OBESE AND HAD PREVIOUS WEIGHT LOSS SURGERIES. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE 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 12736753 ↗
• MalfunctionAug 8, 2021Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING GASTROPLASTY, THE DEVICE HAD A RED LIGHT INDICATOR FAILURE. ANOTHER DISSECTOR AND BATTERY WAS INSTALLED TO ENSURE THAT THE GENERATOR WAS THE CAUSE FOR THE NON-ACTIVATION. USING ANOTHER DISSECTOR AS WELL THEY WERE ABLE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12292144 ↗
• MalfunctionNov 17, 2020Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAP SLEEVE GASTRECTOMY PROCEDURE, THE JAWS WOULD NOT COMPLETELY OPEN AND CLOSE. THE DEVICE DID NOT LOCKED ON TISSUE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10850471 ↗
• MalfunctionSep 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE'S CUTTER TIP COMPLETELY DISENGAGED BUT NOTHING FELL INTO PATIENT'S CAVITY.

  Patient problems: No Information

  MAUDE report 10543909 ↗
• MalfunctionSep 11, 2020Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DISSECTOR DID NOT ACTIVATE. A SIMILAR DEVICE WAS USED TO PROCEED WITH THE CASE. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC INITIAL INVESTIGATIONS FOUND OUT THAT THE TIP OF THE WAVEGUIDE WAS BROKEN OFF AND WAS NOT RETURNED.

  Patient problems: No Patient Involvement

  MAUDE report 10525575 ↗
• MalfunctionMar 31, 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 HAD AN ACTIVATION ISSUE AND THE TIP BROKE DURING THE PROCEDURE. NOTHING FELL INTO THE PATIENT'S CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9908806 ↗
• MalfunctionMar 13, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE'S BLADE TIP BROKE OFF THE DEVICE WAS BEING ACTIVATED WITH JAWS OPEN TO REMOVE IMPLANTED MESH WHEN THE BLADE BROKE. THE BROKEN PIECE OF BLADE WAS RETRIEVED FROM PATIENT BODY CAVITY. THEY REPLACED THE DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9831559 ↗
• MalfunctionOct 24, 2019Intermittent Energy Output; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING VESICULECTOMY, THE DISSECTORS STOPPED WORKING. ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY. INITIAL EVALUATION OF THE SECOND DISSECTOR FOUND THAT THE TIP OF THE WAVEGUIDE WAS BROKEN OFF. THE BROKEN PIECE WAS RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9232989 ↗
• MalfunctionJul 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE TWO DISSECTORS HAD AN ISSUE. THE FIRST ONE SHOWED RED LIGHT DURING THE PROCEDURE. THEY CHANGED THE BATTERY AND GENERATOR BUT THE ISSUE IS THE SAME. THE SECOND DEVICE WORKED FINE. HOWEVER, WHILE CLEANING WITH WET GAUZE THE TIP BROKE OFF. THEY USED ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY. THERE WAS NOTHING FELL INTO PATIENTS CAVITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8811908 ↗
• MalfunctionJan 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ROUX EN Y GASTRIC BYPASS, THE DISSECTOR BLADE BROKE AFTER BEING REMOVED FROM THE PATIENT. THE GENERATOR ALARMED AND THE RED LIGHT INDICATOR ILLUMINATED. THE DEVICE WAS REMOVED FROM PATIENT TO BE WIPED CLEAN BUT WHEN THE DISSECTOR WAS PULLED FROM APPLIED TROCAR THE BLADE BROKE OUTSIDE OF THE PATIENT AND FELL ON THE FLOOR. NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8250593 ↗
• MalfunctionJan 13, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DISSECTOR ALARMED RED DURING USE. WHEN THE DISSECTOR WAS REMOVED FROM PATIENT, THE SURGICAL TECHNOLOGIST WIPED OFF THE BLADE WHICH RESULTED IN THE BLADE BREAKING OFF FROM DISSECTOR. NOTHING FELL INTO THE PATIENT'S CAVITY. THE SURGEON OPENED A NEW DEVICE TO COMPLETE WITHOUT INCIDENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8243060 ↗
• MalfunctionNov 28, 2018Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING ENTEROTOMY IN A GASTRIC BYPASS, THE DEVICE MADE AN ERROR SOUND AND THE TIP OF THE BLADE BROKE OFF INTO THE PATIENTS CAVITY. THEY WERE ABLE TO RETRIEVE THE BLADE. THEY FINISHED THE PROCEDURE USING A DIFFERENT KIND OF DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8110503 ↗
• InjuryOct 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER THE PROCEDURE, THE SURGEON THINKS SEAL WAS INADEQUATE. PATIENT AT ONE POINT HAD BLOOD PRESSURE OF 70/40. PRE-EXISTING CONDITIONS INCLUDE HYPERTENSION, SLEEP APNEA. THE PATIENT WAS NEEDED TO BE BROUGHT BACK TO SURGERY AT THE NIGHT OF THE PROCEDURE FOR ACTIVE BLEEDING OMENTUM.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 8016253 ↗
• MalfunctionOct 23, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING TOTAL LAPAROSCOPIC HYSTERECTOMY, THE DEVICE JAW TIP BROKE AND WAS RETRIEVED. THEY OPENED A NEW DEVICE TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7994672 ↗
• InjuryOct 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THE PROCEDURE WAS COMPLETED USING THE DISSECTOR AND NO BLEEDING WAS VISIBLE AFTER MULTIPLE CHECKS, THE PATIENT WAS CLOSED AND SENT TO POST OPERATION. IT WAS IDENTIFIED THE PATIENT STARTED BLEEDING OVER 500CC AND THEY HAD TO REOPEN TO STOP THE BLEEDING. IT WAS IDENTIFIED THAT IT WAS FROM A MESENTERIC BLEED THAT IN THE CASE WAS FINE BUT AT SOME POINT AFTER BECAME UNSEALED. BLOOD TRANSFUSION WAS DONE TO PATIENT. THE EVENT LEAD TO OR EXTENDED PATIENT HOSPITALIZATION.

  Patient problems: Blood Loss; Exsanguination

  MAUDE report 7943034 ↗
• InjurySep 18, 2018Intermittent Energy Output; Intermittent Energy Output

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE HAND PIECE WAS BEING USED AND STOPPED WORKING DURING CASE, GIVING RED INDICATION. THE BATTERY AND GENERATOR WAS EXCHANGED WITH NO IMPROVEMENT. THE HAND PIECE WAS REPLACED AND WORKED PROPERLY WITH ORIGINAL BATTERY/GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7885401 ↗
• InjuryJul 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, TWO HOURS AFTER COMPLETING A SLEEVE GASTRECTOMY, THE PATIENT WAS BROUGHT BACK TO SURGERY FOR EXCESSIVE BLEEDING. ACTIVE BLEEDING WAS FOUND ON THE MESENTERY OF THE STOMACH AND CONTROLLED. RE-OPERATION WAS DONE DUE TO ACTIVE BLEEDING. THE PATIENT¿S HOSPITALIZATION WAS EXTENDED FOR FIVE DAYS.

  Patient problems: Blood Loss

  MAUDE report 7666531 ↗
• InjuryJul 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, SLEEVE GASTRECTOMY WAS PERFORMED AND NO ACTIVE BLEEDING WAS WITNESSED AT THE TIME OF CLOSING. THREE HOURS LATER, THE PATIENT HAD TO BE RE-OPERATED ON DUE TO EXCESSIVE BLEEDING. SEVENTEEN-HUNDRED (1700) CC WERE LOST AND THE PATIENT WAS GIVEN THREE UNITS OF BLOOD. NO ACTIVE BLEEDING WAS WITNESSED DURING REOPERATION BUT IT WAS SUSPECTED THAT THE BLEEDING CAME FROM THE MESENTERY OF THE STOMACH. THE PATIENT¿S HOSPITALIZATION WAS EXTENDED FOR TWO DAYS.

  Patient problems: Blood Loss; Exsanguination

  MAUDE report 7666444 ↗
• InjuryJul 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, SLEEVE GASTRECTOMY WAS PERFORMED AND NO ACTIVE BLEEDING WAS OBSERVED AT THE TIME OF CLOSING. TWO HOURS LATER, THE PATIENT HAD TO BE RE-OPERATED ON DUE TO EXCESSIVE BLEEDING. THE BLEEDING WAS FOUND ALONG THE MESENTERY OF THE STOMACH AND CONTROLLED WITH SUTURE. A SURGICAL INTERVENTION WAS NEEDED TO PREVENT A PERMANENT IMPAIRMENT. THE PATIENT¿S HOSPITALIZATION WAS EXTENDED THREE TO FIVE DAYS.

  Patient problems: Blood Loss

  MAUDE report 7666338 ↗
• InjuryJun 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BAND REMOVAL PROCEDURE, THE SURGEON NOTICED A BURNT AREA ON THE PATIENTS STOMACH. THE SURGEON SUTURED THE WOUND AND HAS INFORMED THE PATIENT OF THE ISSUE. THE SURGEON WAS WORRIED ABOUT THE SCAB FALLING OFF AND CREATING A HOLE IN THE STOMACH. IT IS UNCERTAIN AS TO WHETHER IT IS A BURN FROM OUR PRODUCT OR THE HOOK DIATHERMY.

  Patient problems: Burn(s)

  MAUDE report 7629350 ↗
• MalfunctionJun 19, 2018Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE THE PHYSICIAN WAS USING THE DEVICE, THE JAW BROKE OFF THE INSTRUMENT. BOTH PIECES OF THE INSTRUMENT WERE REMOVED FROM THE PATIENT AND REMOVED FROM THE SURGICAL FIELD.

  Patient problems: No Information

  MAUDE report 7614419 ↗
• MalfunctionApr 11, 2018Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE TWO DEVICE¿S BLADE SNAPPED OFF FOUR TIMES DURING ACTIVATION. IT WAS SUSPECTED TO BE IN CONTACT WITH METAL. THE BROKEN PIECES THAT FELL INTO PATIENTS CAVITY ARE ALL RETRIEVED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7421018 ↗
• MalfunctionFeb 7, 2018Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE PROCEDURE THE ACTIVE BLADE WAS BROKEN DURING PREPARATION ON TISSUE AND GOT LOST IN THE SITUS. THERE WAS NO INJURY TO THE PATIENT. THE BROKEN SCISSOR BLADES COULD BE REMOVED COMPLETELY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7247761 ↗
• MalfunctionNov 6, 2017Detachment Of Device Component; Detachment Of Device Component

  THE CUSTOMER REPORTED THAT THE DEVICE STOPPED WORKING DURING A PROCEDURE. THE DOCTOR REMOVED THE DEVICE FROM THE TROCAR AND THE JAW FELL OFF THE DEVICE WHEN IT WAS OUTSIDE THE PATIENT. THE BROKEN JAW WAS TAPED TO THE DEVICE FOR RETURN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7005098 ↗