Sonicision SCD13 (UDI 10884521195202)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521195202), received between Jul 11, 2017 and Jul 12, 2021 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 12, 2021Difficult or Delayed Activation; Difficult to Open or Close; Difficult or Delayed Activation; Difficult to Open or Close

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE WAS DIFFICULT TO ACTIVATE AND WOULD NOT OPEN JAW. ANOTHER DISSECTOR WAS USED, AND IT WORKED FINE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12149485 ↗
• MalfunctionMay 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A GYNAE LAPAROTOMY MYOMECTOMY, THE DEVICE'S MOVABLE TIP GOT DISCONNECTED ON THE 5TH ATTEMPT OF USE DURING HEMOSTASIS OF UTERIN TISSUE. THERE WAS NO PATIENT INJURY. PHOTOGRAPH WAS RECEIVED AND SHOWED THAT THE DEVICE'S JAW WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11891142 ↗
• MalfunctionFeb 12, 2021Difficult or Delayed Activation; Detachment of Device or Device Component; Difficult or Delayed Activation; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE WAS DIFFICULT TO ACTIVATE. THEY EXCHANGED FOR ANOTHER PRODUCT TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT. THE MEDTRONIC INITIAL INVESTIGATION OF THE DISPOSABLE DEVICE REVEALED 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 11321220 ↗
• MalfunctionAug 31, 2020Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING RT PARTIAL GLOSSECTOMY AND RIGHT NECK DISSECTION, AFTER ASSEMBLING WITH THE GENERATOR AND BATTERY, THE OPENING AND CLOSING OF THE JAWS ALREADY HAD DIFFICULTY. GENERATOR BEEPED AND RED LIGHT APPEARS WHEN GRASPING TISSUE. THEY TROUBLE SHOOT WITH ANOTHER BATTERY. THE JAW CLOSED BUT HAD PROBLEMS OPENING AT TIMES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10471375 ↗
• MalfunctionSep 29, 2019Detachment of Device or Device Component; Intermittent Energy Output; Detachment of Device or Device Component; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING COLECTOMY, A RED LIGHT APPEARED ON THE POWER AFTER 30 MINUTES OF USING THE DISSECTOR AND THE TIP WAS FOUND TO BE BROKE OFF. BATTERY AND GENERATOR WERE CHANGED BUT THE PROBLEM STILL PERSISTED. A NEW DISSECTOR WAS OPENED TO COMPLETE THE PROCEDURE. NO PART OF THE DEVICE FELT INTO PATIENT CAVITY AND WAS PACKAGED IN A COMPRESS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9132608 ↗
• MalfunctionSep 24, 2019Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, CUTTER JAWS COULDN'T BE CLOSED NORMALLY DURING THE THYROIDECTOMY. THERE WAS NO PATIENT INJURY. COMMUNICATIONS FROM THE INVESTIGATIONS STATED THAT THE DEVICE DID NOT LOCK ON TISSUE NOR TISSUE RESECTION WAS NECESSARY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9108283 ↗
• MalfunctionMar 11, 2019Intermittent Energy Output; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE DID NOT ACTIVATE. AFTER 3 AND A HALF HOURS THE EQUIPMENT STOPPED PERFORMING THE DISSECTION. THE BATTERY WAS CHANGED, BUT CONTINUED TO PRESENT THE PROBLEM. TO FINALIZE THE PROCEDURE, THE TWEEZERS WERE REPLACED WITH ANOTHER ONE FROM THE SAME LOT AND IT WORKED WITHOUT INTERCURRENCES. THERE WAS NO PATIENT INJURY. IT HAS CONFIRMED THAT THE TIP DID NOT BREAK AND NOTHING FELL INTO THE PATIENT CAVITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8407840 ↗
• MalfunctionMar 7, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PRIOR TO USE, UPON ASSEMBLY, THE DEVICE DID NOT ACTIVATE WHEN HANDED TO THE SURGEON. THE SAME BATTERY AND GENERATOR WORKED WITH ANOTHER DEVICE TO START THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8398721 ↗
• MalfunctionJan 17, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING TOTALLY LAPAROSCOPIC TOTAL GASTRECTOMY (TLTG) PROCEDURE, THE RED LIGHT CAME ON AND IT DID NOT ACTIVATE. THEY REPLACED THE BATTERY AND THE GENERATOR, BUT IT DID NOT WORK. THE JAW WAS BROKEN WHEN THEY TRIED TO WIPE IT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8259268 ↗
• InjuryJan 10, 2019Defective Device; Defective Device

  THE DEVICE WAS RETURNED WITHOUT ANY ACCOMPANYING INFORMATION. INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THESE TWO DISPOSABLE DEVICE REVEALED THAT THE TIP OF THE WAVEGUIDE WAS BROKEN OFF. THE BROKEN PIECE WAS NOT RETURNED.

  Patient problems: No Information

  MAUDE report 8236204 ↗
• MalfunctionDec 4, 2017Overheating of Device; Self-Activation or Keying; Overheating of Device; Self-Activation or Keying

  ACCORDING TO THE REPORTER, DURING A THYROID LOBECTOMY, THE DEVICE¿S JAWS AND SHAFT WAS HOTTER THAN IN PREVIOUS USES. AFTER ACTIVATION AND APPLYING THE JAWS FOR A SUBSEQUENT BITE, THE JAWS WOULD BEGIN TO CREATE TISSUE EFFECT WITHOUT EVEN DEPRESSING THE BLUE ENERGY BUTTON. THE PATIENT ALSO HAD SOME MINOR BLANCHING OF THE SKIN CREATED BY THE SHAFT COMING IN CONTACT WITH THE SKIN. MEDICAL INTERVENTION WAS NOT REQUIRED.

  Patient problems: Injury

  MAUDE report 7080736 ↗
• MalfunctionJul 11, 2017Device Stops Intermittently; Device Stops Intermittently

  THE CUSTOMER ORIGINALLY REPORTED THAT THE DEVICE STOPPED WORKING DURING THE PROCEDURE. ANOTHER DISSECTOR WAS OPENED AND USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY. THE DEVICE WAS RETURNED FOR EVALUATION AND A PIECE OF THE ACTIVE WAVEGUIDE WAS DISENGAGED FROM THE DEVICE. THE BROKEN PIECE WAS RETURNED WITH THE REMAINDER OF THE DISSECTOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6700795 ↗