Sonicision SCDA48Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10884521592858), received between Oct 1, 2019 and Mar 16, 2026 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 reports).

2 other recalls cover devices cleared under the same FDA submission (K180149); they may or may not involve this specific model.

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026Failure to Fire; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DISSECTOR WOULD NOT TO ACTIVATE. THE DISSECTOR DID NOT COME INTO CONTACT WITH ANY METAL INSTRUMENT. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE DISSECTOR HAD A FRACTURED WAVEGUIDE. THE WAVEGUIDE WAS NOT RETURNED WITH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24605238 ↗
• MalfunctionJan 28, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, TOWARDS THE END OF A LAPAROSCOPIC SLEEVE GASTRECTOMY AND PROXIMAL JEJUNAL BYPASS, THE WHITE PLASTIC ON THE MOVING JAW HAD DROPPED OUT ONCE SURGEON TOOK IT OUT FROM THE PATIENT CAVITY. NOTHING FELL ON PATIENT'S CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24206226 ↗
• MalfunctionJan 8, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, PRIOR TO USE, THE DISSECTOR'S WHITE MATERIAL ON THE NON-ACTIVE JAW HAD COME OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24008091 ↗
• MalfunctionOct 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, TOWARDS THE END OF THE PROCEDURE, THE WHITE PAD ON THE JAW OF THE DEVICE WAS FALLING OFF OR MELTING. THE DISSECTOR DID NOT COME INTO CONTACT WITH ANY METALLIC INSTRUMENT. NOTHING FELL OFF IN PATIENT, X-RAY WAS NOT NECESSARY. THERE WAS NO RED LIGHT ON THE DEVICE. THEY OPENED A NEW DISSECTOR TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17951486 ↗
• MalfunctionOct 3, 2022Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, THE HANDPIECE WOULD NOT POWER UP. GOT RED LIGHT INSTEAD OF GREEN. THE HANDPIECE WOULD NOT POWER CORRECTLY UPON ASSEMBLING OF THE DEVICE BEFORE THE CASE STARTED. THEY TRIED TO DISASSEMBLE THE GENERATOR AND BATTERY AND RECONNECT TO THE HANDPIECE. THEY TRIED ANOTHER GENERATOR AND BATTERY AND IT STILL WOULD NOT WORK, SO THEY GOT A SECOND HANDPIECE AND IT WORKED UPON SET UP. THE DISSECTOR DID NOT BROKE AND NOTHING FELL ON THE PATIENT'S CAVITY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND UPON VISUAL INSPECTION OF THE DISPOSABLE DEVICE REVEALED THAT THE DISSECTOR HAD A FRACTURED WAVEGUIDE, THE TIP WAS RETURNED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15530245 ↗
• MalfunctionAug 18, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER A FEW MINUTES OF FIRING, GENERATOR START GIVING RED ALARM AND NO ACTIVATION WAS POSSIBLE.  THE DEVICE WAS CHECKED WITH 2 DIFFERENT GENERATOR AND BATTERY AND THE DEVICE DID NOT WORK. NOTHING COMPLETELY BROKE OFF FROM THE DEVICE. ANOTHER DEVICE WAS USED WITH THE SAME GENERATOR AND BATTERY AND WORKED FINE. BASED ON THE INVESTIGATION, THE TITANIUM WAVEGUIDE WAS IN USE WHEN IT FRACTURED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15250388 ↗
• MalfunctionMay 9, 2022Entrapment of Device; Difficult to Open or Close; Entrapment of Device; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING RYGB (ROUX-EN-Y GASTRIC BYPASS), A FEW FIRING IN THE FIRST 5 MINUTES, THE DISSECTOR'S JAW MOVEMENT WAS NOT PROPER AND IT KEPT GETTING STUCK WHEN CLOSED. THE DISSECTOR WAS BEING APPLIED ON A TISSUE WHEN THE EVENT HAPPENED AND THE TISSUE GOT CAUGHT ON THE JAW. THE SURGEON HAD TO PRESS THE LEVER MULTIPLE TIMES TO MAKE THE JAW OPEN. THE KNIFE BLADE DID NOT PROTRUDE BEYOND THE EDGE OF THE JAWS. THE DEVICE WAS REPLACED WITH ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14342728 ↗
• MalfunctionFeb 16, 2022Therapeutic or Diagnostic Output Failure

  DEVICE WAS NOT DISSECTING TISSUE WELL ENOUGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13541453 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE CLAMP WAS USED TO TAKE SPLENIC ARTERY WHILE MOBILIZING THE STOMACH IN PREPARATION FOR MAKING THE GASTRIC POUCH. LOW ACTIVATION WAS USED WITH NO TENSION APPLIED. THE DEVICE DID NOT SEAL AND THERE WAS A SPLENIC RUPTURE. THERE WAS HEAVY BLEEDING AND SURGEON IMMEDIATELY INSERTED A RAYTEC TO STOP BLEEDING. THREE (3) RAYTECS WERE INSERTED INTO THE ABDOMEN AT WHICH POINT ANESTHESIA WAS PREPARING TO CONVERT TO OPEN IF NEEDED. SURGEON CONTINUED POUCH AND CAME BACK TO BLEEDING ONCE THE RAYTECS SLOWED IT DOWN. LIGASURE WAS USED TO SEAL SPLENIC ARTERY ONCE LOCATED. PROCEDURE WAS COMPLETED. SCDA48 APPEARED TO BE INCONSISTENT AND UNRELIABLE FOR THE SPLENIC SEAL. THREE (3) EACH OF SCDA48 WERE BEING SENT BECAUSE DEVICE WAS ACCIDENTALLY PLACED INTO STRYKER RECYCLING BIN IN WHICH THERE WERE TWO (2) OTHER SCDA48 UNITS IN THERE ALREADY. UNABLE TO DETERMINE WHICH OF THE THREE (3) WAS USED IN THIS PROCEDURE. SURGEON REQUESTING ALL THREE (3) BE TESTED FOR INEFFICIENCIES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11844849 ↗
• InjuryMay 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTRIC BYPASS, THE DEVICE HAD AN UNRELATED ISSUE WHEN WORKING AROUND THE GASTRIC POUCH. THE SURGEON WAS WORKING TO DIVIDE THE SHORT GASTRIC ARTERIES WITH THE DEVICE HOWEVER, THE SURGEON WAS ALSO WORKING NEXT TO THE SUPERIOR POLE OF THE SPLEEN. THE ANATOMY WAS LIKELY A SPLENIC ARTERY TRIBUTARY TO THE SUPERIOR PORTION OF THE SPLEEN. THE SURGEON WAS UNSURE IF THE SHORT GASTRIC OR THIS SPLENIC TRIBUTARY WAS DIVIDED WITH THE DEVICE, BUT THE RESULT WAS SIGNIFICANT AND UNCONTROLLABLE BLEEDING AFTER ACTIVATING THE DEVICE. THE CASE CONVERTED FROM LAPAROSCOPIC TO OPEN AND SPLEEN WAS REMOVED TO STOP HEMORRHAGE FROM SPLENIC ARTERY. AN INCIDENTAL SPLENECTOMY WAS REQUIRED DUE TO SPLENIC ARTERY TRAUMA. HOSPITALIZATION WAS EXTENDED AND BLOOD TRANSFUSION WAS NEEDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 11809096 ↗
• MalfunctionFeb 23, 2021Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, SURGEON HAD AN ISSUE WITH OPENING AND CLOSING THE HANDPIECE AS THEY WERE STICKING. A SIMILAR DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11369258 ↗
• MalfunctionJan 28, 2020Intermittent Energy Output; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LONGITUDINAL GASTRECTOMY , THE HAND PIECE STOPPED WORKING AND ALARMED WITH RED LIGHT AFTER THEY USED FOR ABOUT 30 SECONDS. SCRUB CHECK DID CHECK HAND PIECE BEFORE USING AND WITH NO ISSUE. ALARMED AFTER TRYING TO CUT TISSUE. MULTIPLE CHARGED BATTERIES USED AND STILL DID NOT WORK. OPENED AND USED NEW HAND PIECE AND IT WORKED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9638974 ↗
• MalfunctionJan 8, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, A PORTION OF THE DEVICE BROKE OFF AND WAS ABLE TO RETRIEVE.

  Patient problems: No Information

  MAUDE report 9562192 ↗
• InjuryOct 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING BYPASS PROCEDURE AND NORMAL ACTIVATION, THE JAWS OF THE DEVICE BROKE OFF AND FELL INTO THE PATIENT CAVITY. THEY COULD NOT FIND IT AND HAD TO USE THE C-ARM (X-RAY) TO IDENTIFY IT FOR REMOVAL.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 9143613 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K180149. One submission often covers many models, so check the product and lot details in each record.

• Z-0332-2022 · Nov 12, 2021 · Open, Classified
  Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status Item
• Z-2240-2021 · Jun 23, 2021 · Terminated
  Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade. Product Number: SCGAA